June 22, 2015 — The U.S. Food and Drug Administration today approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing percutaneous coronary intervention (PCI), a procedure used to open a blocked or narrowed coronary artery to improve blood flow to the heart muscle.
According to the Centers for Disease Control and Prevention, PCI is performed on approximately 500,000 people in the United States each year. The coronary arteries are opened by inflating a balloon at the site of the narrowing, usually followed by placement of a small mesh tube, called a stent, to keep the artery open.By preventing platelets from accumulating, Kengreal reduces the risk of serious clotting complications related to the procedure, including heart attack and clotting of the stent (stent thrombosis).“For patients undergoing percutaneous coronary intervention, blood clotting can cause serious problems,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “The approval of Kengreal provides another treatment option for patients.”
As with other FDA-approved anti-platelet drugs, bleeding, including life-threatening bleeding, is the most serious risk of Kengreal.In a clinical trial that compared Kengreal to Plavix (clopidogrel) in more than 10,000 participants, Kengreal significantly reduced the occurrence of heart attack, the need for further procedures to open the artery and stent thrombosis. The overall occurrence of serious bleeding was low but more common with Kengreal than with clopidogrel. Approximately one in every 170 Kengreal patients had a serious bleed versus approximately one in every 275 clopidogrel patients.
Kengreal is manufactured by The Medicines Company based in Parsippany, New Jersey.
Generic Name: olodaterol and tiotropium bromide Date of Approval: May 21, 2015 Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Stiolto Respimat is a combination of the long-acting beta2-adrenergic agonist olodaterol (Striverdi Respimat), and the anticholinergic agent tiotropium (Spiriva Respimat).
The U.S. Food and Drug Administration (FDA) has approved Stiolto Respimat (olodaterol and tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is not indicated for the acute symptoms of COPD, or for asthma, and does not replace the use of a rescue inhaler.
Medication Guide
Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.
Important information
Stiolto Respimat has been approved for the treatment chronic obstructive pulmonary disease (COPD) only. It is not to be used in the treatment of asthma.
Stiolto Respimat can cause serious side effects, including:
People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as olodaterol (one of the medicines in Stiolto Respimat), have an increased risk of death from asthma problems.
It is not known if LABA medicines, such as olodaterol, increase the risk of death in people with COPD.
Get emergency medical care if:
breathing problems worsen quickly
you use your rescue inhaler medicine, but it does not relieve your breathing problems
What is Stiolto Respimat?
Stiolto Respimat contains two ingredients: olodaterol, a long-acting beta2-adrenergic agonist (LABA), and tiotropium, an anticholinergic agent.
It is used long term, two puffs once each day, in controlling symptoms in adults with COPD.
LABA and anticholinergic medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.
Stiolto Respimat is not for use to treat sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
It is not known if this medicine is safe and effective in people with asthma. It should not be used in children. It is not known if Stiolto Respimat is safe and effective in children.
Who should not use this medicine?
Do not use Stiolto Respimat if:
you have asthma.
you are allergic to tiotropium, ipratropium, olodaterol, or any of the ingredients. See the end of this Medication Guide for a complete list of active and inactive ingredients.
Before using Stiolto Respimat
Tell your healthcare provider about all of your health conditions, including if you:
have heart problems
have high blood pressure
have seizures
have thyroid problems
have diabetes
have eye problems, such as glaucoma. This medicine can make your glaucoma worse.
have prostate or bladder problems, or problems passing urine. This medicine can make these problems worse.
have any other medical conditions
are pregnant or planning to become pregnant. It is not known if this medicine can harm your unborn baby.
are breastfeeding. It is not known if the active ingredients pass into your breast milk and if they can harm your baby.
are allergic to Stiolto Respimat or any of its ingredients, any other medicines, or food products.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, eye drops, vitamins, and herbal supplements. Stiolto Respimat and certain other medicines may interact with each other. This may cause serious side effects.
Especially tell your healthcare provider if you take:
anticholinergics (including ipratropium, aclidinium, umeclidinium or another tiotropium-containing product such as Spiriva Respimat or Spiriva HandiHaler)
atropine
Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.
How should I use Stiolto Respimat?
Read the step-by-step instructions contained in the product package.
The inhaler has a slow-moving mist that helps you inhale the medicine.
Use Stiolto Respimat exactly as your healthcare provider tells you to use it.
Use ONE dose (TWO puffs) of Stiolto Respimat, one time each day, at the same time of the day.
If you miss a dose, take it as soon as you remember. Do not take more than ONE dose (TWO puffs) in 24 hours.
Do not spray the inhaler in your eyes.
Always use the new inhaler that is provided with each new prescription.
Stiolto Respimat does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your healthcare provider to have one prescribed for you.
Do not stop using this medicine, or other medicines used to control or treat your COPD unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
Do not use Stiolto Respimat:
more often than prescribed for you, or
with other medicines that contain LABA or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic medicines.
Call your healthcare provider or get emergency medical care right away if:
your breathing problems worsen during treatment
you need to use your rescue medicine more often than usual
your rescue inhaler medicine does not work as well for you at relieving your symptoms
Stiolto Respimat side effects
Stiolto Respimat can cause serious side effects, including:
See Important information
If your COPD symptoms worsen over time do not increase your dose. Call call your healthcare provider instead.
sudden shortness of breath that may be life-threatening
serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.
heart problems including fast or irregular heartbeat, palpitations, chest pain, increased blood pressure
new or worsening eye problems including acute narrow-angle glaucoma. Symptoms of acute narrow-angle glaucoma include eye pain or discomfort, blurred vision, seeing halos or colored images around lights, and red eyes. Call your healthcare provider right away if you have any of these symptoms. Use caution as some of these eye problems can affect your ability to drive and operate appliances and machinery.
new or worsening urinary retention. Symptoms of urinary retention may include difficulty urinating, painful urination, urinating frequently, or urinating in a weak stream or drips. Call your healthcare provider right away if you have any of these symptoms.
low blood potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm)
high blood sugar
Common side effects of Stiolto Respimat include runny nose, cough, and back pain.
Tell your healthcare provider about any side effect that bothers you or that does not go away.
This is not a complete list of side effects. Ask your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.
How should I store Stiolto Respimat?
Store Stiolto Respimat at room temperature between 68°F to 77°F (20°C to 25°C).
Do not freeze the cartridge or the inhaler.
Keep all medicines out of the reach of children.
General Information about the safe and effective use of Stiolto Respimat
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it toother people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about Stiolto Respimat. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information that was written for healthcare professionals.
For more information, including a video demonstration on how to use Stiolto Respimat, go to www.stiolto.com.
What are the ingredients in Stiolto Respimat?
Active ingredients: olodaterol and tiotropium bromide
Inactive ingredients: water for injection, benzalkonium chloride, edetate disodium, and hydrochloric acid
Generic Name: perampanel (per AM pa nel) Brand Names:Fycompa
What is Fycompa?
Fycompa (perampanel) is an anticonvulsant used to treat seizures.Fycompa is a prescription medicine that is used with other medications to treat partial-onset seizures with or without secondarily generalized seizures, and to treat primary generalized tonic-clonic (PGTC) seizures, in adults and children who are at least 12 years old.Fycompa may also be used for purposes not listed in this medication guide.
Introduction
Anticonvulsant; a noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA)-type glutamate receptor antagonist.
Uses for Fycompa
Seizure Disorders
Management (in combination with other anticonvulsants) of partial-onset seizures in patients ≥12 years of age with epilepsy.Management (in combination with other anticonvulsants) of primary generalized tonic-clonic seizures in patients ≥12 years of age with epilepsy.Designated an orphan drug by FDA for treatment of Lennox-Gastaut syndrome; not FDA-labeled for this orphan indication.
Fycompa Dosage and Administration
General
When discontinuing anticonvulsant therapy, gradual withdrawal is recommended to minimize potential for increased seizure frequency.1 (See Discontinuance of Anticonvulsants under Cautions.)
Closely monitor for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression. (See Suicidality Risk under Cautions.)
June 12, 2015 — The U.S. Food and Drug Administration today approved the Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential tremor, a movement disorder that is one of the most common causes of tremors. The Brio Neurostimulation System can help some patients when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance problems, and tremors.
An estimated 50,000 Americans are diagnosed with Parkinson’s disease each year, according to the National Institutes of Health, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement — like eating, writing and shaving.
Essential tremor affects several million people and usually occurs in those over age 40. “There are no cures for Parkinson’s disease or essential tremor, but finding better ways to manage symptoms is essential for patients,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This new device adds to the array of treatment options to helppeople living with Parkinson’s and essential tremor enjoy better, more productive lives.”
The Brio Neurostimulation System consists of a small (1.9in x 2.1in x 0.4in) battery-powered, rechargeable electrical pulse generator implanted under the skin of the upper chest and wire leads that attach to electrodes placed within the brain at specific locations depending on whether the device is being used to treat Parkinson’s disease or essential tremor. The electrical pulse generator continuously delivers low intensity electrical pulses to target areas in the brain. Health care providers make adjustments to the pulse generator to optimize the effects of the Brio Neurostimulation System.
Data supporting the safety and effectiveness of the device system included two clinical studies. One study included 136 patients with Parkinson’s disease and the other included 127 patients with essential tremor. In both studies, patients had symptoms, including tremors, that were not adequately controlled with drug therapy.
The Brio Neurostimulation System was used in addition to medication for patients with Parkinson’s disease and the majority of patients with essential tremor who used the device were able to control their symptoms without the need for medications. Researchers implanted the Brio Neurostimulation System in all patients and assessed effectiveness for Parkinson’s disease patients at three months and essential tremor patients at six months. Both groups showed statistically significant improvement on their primary effectiveness endpoint when the device was turned on compared to when it was turned off.
Serious adverse events included intracranial bleeding, which can lead to stroke, paralysis or death. Other device-related adverse events included infection and dislocation of the device lead under the skin. The Brio Neurostimulation System is manufactured by St. Jude Medical in St. Paul, Minnesota.
Brio Neurostimulation System is the second device approved by the FDA for Parkinson’s and essential tremor. The first device, Medtronic’s Activa Deep Brain Stimulation Therapy System, was approved in 1997 for tremor associated with essential tremor and Parkinson’s disease. In 2002, the indications were expanded to include the symptoms of Parkinson’s disease.
In its early stages, Parkinson’s disease typically affects one side of the body and starts as problems with movement, stiffness, and mild tremors. Gradually, the symptoms can affect both sides of the body and medications may become less effective. People with late stage Parkinson’s disease have many symptoms including: trouble walking, impaired posture and balance, muscle stiffness and tremors in the arms and hands that make it difficult to perform everyday tasks.
Essential tremor most often affects the hands and arms and can be slowly progressive, starting on one side of the body but eventually affecting both sides. Hand tremor is the most common symptom, but tremors can also affect movement in the head, arms, voice, tongue, legs, and trunk. About half of essential tremor cases result from a genetic mutation. For the remainder of cases, the cause is unknown.
An advisory committee for the Food and Drug Administration has recommended the approval of a novel, injectable cholesterol-lowering drug called alirocumab, though many committee members have noted certain restrictions for its use and have requested further data on the drug’s ability to reduce the risk of heart problems.
According to the Centers for Disease Control and Prevention (CDC), around 73.5 million people in the US have high levels of “bad” cholesterol, known as low-density lipoprotein (LDL). What is more, less than half of adults with high LDL cholesterol are receiving treatment for the condition.High cholesterol is a major risk factor for heart disease, putting individuals at twice the risk for the condition. Lowering LDL cholesterol can significantly reduce the risk of heart disease, as well as the risk of heart attack, stroke and other cardiovascular conditions.
At present, a class of drugs called statins are the standard treatment for high LDL cholesterol and have been for the past 2 decades. Statins lower levels of LDL cholesterol by interfering with an enzyme called HMG-CoA reductase, which is responsible for cholesterol production in the liver.However, though statins are an effective class of cholesterol-lowering drugs, they can produce a number of side effects, including muscle pain, liver damage, digestive problems and increased blood sugar. Research has also linked statin use to memory loss, though a recent study claims this is not due to the drugs themselves.
Alirocumab (brand name Praluent) lowers LDL cholesterol by inhibiting PCSK9 (proprotein convertase subtilisin/kexin type 9) – a protein that impairs the liver’s ability to remove cholesterol from the blood.According to the drug manufacturers – Regeneron and Sanofi – alirocumab is safer and more effective than statins for reducing high LDL cholesterol.Their conclusion is based on the findings of a phase 3 clinical program involving more than 5,000 patients with high LDL cholesterol, including some who are not able to tolerate statins. The findings revealed a 75-mg dose of Praluent reduces LDL cholesterol by around 50%, while a 150-mg dose results in a 60-65% reduction.
PANELISTS VOTE 13-3 IN FAVOR OF ALIROCUMAB APPROVAL, BUT WITH RESTRICTIONS
In a meeting on Tuesday, the Food and Drug Administration (FDA) advisory committee took the results of the phase 3 clinical program into account when deciding whether to recommend approval for alirocumab as a treatment for patients with high LDL cholesterol.
The committee voted 13-3 in favor of alirocumab approval, claiming that the research has demonstrated that “alirocumab is well-tolerated and provides substantial reductions in LDL-C [LDL cholesterol] for a population of patients whose LDL-C is not adequately controlled with existing therapies.”
However, while Regeneron and Sanofi seek approval for alirocumab as a treatment for a large proportion of patients with high cholesterol, if the drug is given the green light by the FDA, its use may be much more restricted.Some members of the advisory committee said – based on current data – they recommend it be used to treat patients with abnormally high cholesterol triggered by a genetic disorder known as familial hypercholesterolemia (FH), and they said more data is needed on its effectiveness to reduced heart conditions before they can recommend its use in wider populations.Nine of the 16 committee members said they believe alirocumab should be offered to patients at high risk of cardiovascular disease as a result of factors that cannot be controlled with statins.Only seven panelists recommended alirocumab use for patients who are unable to tolerate statins due to side effects, with many of these stating the drug should be used in combination with a tolerable level of statins.
But despite these caveats, Regeneron and Sanofi are pleased with the outcome of the FDA advisory committee’s meeting. Dr. George D. Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories, says:
“The discovery of PCSK9 as a powerful regulator of cholesterol levels and cardiovascular disease was one of the most important human genetic advances of the last decade.
Today’s outcome brings us one step closer to translating this genetics-based discovery into a treatment that may help the many patients in need of additional cholesterol lowering.”
It is estimated that if the FDA does grant approval for alirocumab, the drug would cost around $7,000-$12,000 per patient annually, while brand-name statins cost around $500-$7,000 per patient each year.Talking to CNN, however, Dr. Eliiott Antman, president of the American Heart Association, said alirocumab can be a cost-effective treatment option for patients with high cholesterol.”If we [balance] the cost of these drugs over society and the cost to our health care system for caring for patients who suffer the consequences of vascular disease,” he said, “it’s possible that the calculus would suggest this could be a cost effective and attractive approach.”
The FDA will make their final decision on whether to approve alirocumab later this summer, though they are expected to follow the recommendation of the advisory committee.
Today, the FDA advisory committee is meeting to make recommendations on another PCSK9 inhibitor called evolocumab (brand name Repatha) – manufactured by Amgen Inc.
Alectinib, a new drug for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer, has been approved by the US Food and Drug Administration (FDA).Alectinib, marketed as Alecensa by Genentech, has been licensed for patients who cannot tolerate crizotinib or whose disease has worsened after treatment with the drug.Alectinib was studied in two trials involving patients with metastatic disease for whom crizotinib, marketed as Xalkori by Pfizer, was no longer effective.
In the first study, 38% of patients had partial shrinkage of their tumours, lasting 7.5 months. In the second study, 44% of patients had partial tumour shrinkage lasting 11.2 months on average. For most patients, alectinib was effective at shrinking metastases in the brain, one of the most common places for lung cancer to spread.About 4-5% of non-small cell lung cancer patients are ALK-positive — the gene mutation is usually found in younger patients with no or light smoking history. The ALK subtype is the result of a chromosomal rearrangement that creates a novel gene that drives the formation of cancer.
Crizotinib, the first drug to target ALK-positive lung cancer, was approved by the FDA in November 2013 and by the European Medicines Agency (EMA) in November 2012. Since the approval of crizotinib, ceritinib has also been approved in the United States and Europe, making alectinib the third drug to be licensed for the disease.“[This] approval provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with Xalkori,” says Richard Pazdur, director of the Office of Hematology and Oncology Products at the FDA.Alectinib is currently under evaluation by the EMA.The main side effects associated with alectinib are fatigue, constipation, swelling and muscle pain.
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