BrainBlog

From the FDA: FDA NEWS RELEASE For Immediate Release: Oct. 24, 2011 FDA approves Onfi to treat severe type of seizures On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended to treat a disease or condition that affects fewer than 200,000 people in the United States, it was granted orphan drug designation by the FDA. “Lennox-Gastaut syndrome is a severe form of epilepsy that causes debilitating seizures,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This is a difficult condition to treat, and it will be helpful to have an additional treatment option.” Read the full release

A fuller report from The New York Times : F.D.A. Sees Promise in Alzheimer’s Imaging Drug By GINA KOLATA The New York Times Published: January 20, 2011 "A committee voted that the agency should approve the first test that can show the characteristic plaques of Alzheimer’s disease in the brain of a living person." Read the full article

From The New York Times : F.D.A. Sees Promise in Alzheimer’s Imaging Drug By THE ASSOCIATED PRESS Published: January 20, 2011 Filed at 5:40 p.m. EST WASHINGTON (AP) — A federal panel of medical experts said Thursday a first-of-a-kind imaging chemical designed to help screen for Alzheimer's disease could be useful pending additional study and training for physicians. The Food and Drug Administration panel of advisers voted 16-0 in favor of approval for Eli Lilly's Amyvid on the condition that the company demonstrates the images can be consistently interpreted by physicians who have received training in reading the scans. Without those requirements the panel voted 13-3 against approval for the injection in an earlier vote. The FDA is not required to follow the panel's advice, though it often does. Read the full report

From the FDA (.pdfs of briefing material is available at the link below): January 20-21, 2011: Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement Read the full announcement Agenda "On January 20, 2011, the committee will discuss new drug application (NDA) 202-008, florbetapir F 18 injection, sponsored by Avid Radiopharmaceuticals, Inc. , proposed for use in positron emission tomography (PET) imaging of β-amyloid (beta-amyloid) aggregates in the brain to help rule out Alzheimer's disease. "On January 21, 2011, the committee will discuss NDA 201-277, gadobutrol injection, sponsored by Bayer HealthCare Pharmaceuticals, proposed for use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity (abnormal blood supply and circulation) of the central nervous system. The BBB is an area consisting of specialized ...

From The New York Times : Tests Show Promise for Early Diagnosis of Alzheimer’s By GINA KOLATA The New York Times Published: January 18, 2011 "Researchers report major advances on two vexing questions about Alzheimer’s: How do you know if someone who is demented has it? And how can you screen the general population for risk?" Read the full article. The report includes discussion about this week's forthcoming FDA Advisory Committee discussion about Avid Radiopharmaceuticals product.

FDA rejects a new epilepsy drug from Valeant, GSK FierceBiotech 02 December 2010 Read FierceBiotech article here === Earlier blog post on topic, from 12th August: here ===

From FierceBiotech FDA panel backs new epilepsy drug from GSK, Valeant August 12, 2010 — 7:41am ET By John Carroll "GlaxoSmithKline and Valeant got a solid endorsement for their new epilepsy drug Potiga (ezogabine) from the FDA's panel of experts, putting them on track to a likely approval. The experts unanimously agreed that the drug would benefit epilepsy patients whose meds couldn't stop seizures. And they agreed that careful monitoring would flag patients who experience an inability to urinate while taking the drug." Read the full article

From FierceBiotech : FDA approves Acorda's new MS drug January 22, 2010 — 4:49pm ET By John Carroll [snip] The FDA announced Friday afternoon that it has approved Ampyra (dalfampridine) extended-release tablets to improve walking in patients with multiple sclerosis. In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with a placebo. This is the first drug approved for this use. [snip] Read the FierceBiotech full article

From the FDA: Information on Natalizumab (marketed as Tysabri) Updated Information: [9/2009] The FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008. From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy. Of these, four cases were patients in the United States (U.S.). There have been no postmarketing reports of PML in patients treated with Tysabri for Crohn’s disease. Less than 2% of Tysabri use in the U.S. has been in patients with Crohn's disease. The risk for developing PML appears to increase with the number of Tysabri infusions received. The number of monthly infusions of Tysabri in the 13...

From a press release by the FDA: Sabril Approved by FDA to Treat Spasms in Infants and Epileptic Seizures Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children ages 1 month to 2 years. Sabril is the first drug in the United States approved to treat the disorder, characterized by a severe type of seizure that usually appears in the first year of life, typically between ages 4 months and 8 months. The disorder can be debilitating because of the frequency of difficult-to-control daily seizures. Sabril (vigabatrin) Tablets have been approved for adult use in combination with other medications to treat complex partial seizures that have not responded adequately to previous drug therapies. “Seizures can cause impaired nervous system function and reduced quality of life,” said Russell Katz, M.D., director of the Division of Neurology Products at the FDA’s Center for Drug Evaluation and Research. “Infantile spasms i...

From the FDA: FDA Approves Saphris to Treat Schizophrenia and Bipolar Disorder The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to treat bipolar I disorder in adults, a serious psychiatric disorder that causes shifts in a person's mood, energy, and ability to function. “Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Effective medicines can help people with mental illness live more independent lives.” Read the full FDA press release S-P corporate press release

Available in a .pdf document from the "What's New" page of the OIG website here: Link for OIG webpage .

An FDA press release from yesterday: FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents The U.S. Food and Drug Administration today approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17. This is the first FDA approval of an atypical antipsychotic drug to treat either disorder in these age groups. Until now, there has been no FDA-approved drug for the treatment of schizophrenia for pediatric use and only lithium is approved for the treatment of bipolar disorder in adolescents ages 12 and up. “The pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose, and safety of using this product in the pediatric population,” said Dianne Murphy, M.D., director of FDA’s Office of Pediatric Therapeutics. “These data have permitted the identification of the effectiv...