FDA to review prasugrel for acute coronary syndromes
There is no cure for spinal muscular atrophy (SMA), a genetic disorder that causes the weakening of muscles and is the leading genetic cause of infant death, but University of Missouri researchers have discovered a new therapeutic target that improves deteriorating skeletal muscle tissue caused by SMA. The new therapy enhanced muscle strength, improved gross
Full Post: Discovery of target that could ease spinal muscular atrophy symptoms
Daiichi Sankyo Company, Limited and Eli Lilly and Company has confirmed that the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) will review prasugrel during an advisory committee hearing on February 3, 2009.
Prasugrel is an investigational antiplatelet agent for the treatment of patients with acute coronary syndromes (ACS) who are being managed with an artery-opening procedure known as percutaneous coronary intervention (PCI), which is usually followed by the placement of a stent to help keep the artery open.
Advisory committees provide the FDA with independent advice from outside medical experts during the review process. The companies will have further discussions with the FDA in preparation for the Advisory Committee Meeting.
“We welcome the opportunity to discuss any and all of the prasugrel data with the advisory committee and the agency, just as we have throughout the ongoing review,” said John Alexander M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Limited.
“We have full confidence in the data submitted to the FDA and the overall benefit-risk profile of prasugrel, and we look forward to this next step in potentially bringing an important new alternative to the oral antiplatelet market,” said J. Anthony Ware, M.D., Lilly vice president and cardiovascular/acute care platform leader for prasugrel.
Acute coronary syndromes (ACS), which is comprised of heart attacks and unstable angina (chest pain), affects more than 1.4 million people in the United States annually.(i) Coronary heart disease, which can result in ACS, is the single most common cause of death in the European Union, accounting for more than 741,000 deaths in the EU each year.(ii) Coronary artery disease occurs when the arteries become narrowed or clogged by cholesterol and fat deposits and cannot supply enough blood to the heart. In some cases, a blood clot may partially or totally block the blood supply to the heart resulting in ACS.(iii) Many ACS patients are managed with PCI, which usually includes a stent placement.
The U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee today voted unanimously to recommend approval of Bausch & Lomb’s besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis. The company has developed this broad-spectrum, anti-infective drop specifically for ophthalmic use. All new chemical entities such as besifloxacin, a fluoroquinolone, must
Full Post: FDA Advisory Committee Recommends Approval of Bausch & Lomb Besifloxacin Anti-Infective Eye Drop
Despite substantial progress in the diagnosis and treatment of heart attack patients, prevention of recurrent heart attacks continues to be a major clinical challenge. A new study showed that patients who suffered a non-fatal heart attack within the first three months of hospitalization for chest pain had a significantly higher risk for dying or having
Full Post: Heart attack prevention within three months after hospitalization significantly averted future attacks
Individually tailored anti-clotting medication dosing significantly cut the rate of adverse events after non-emergent percutaneous coronary intervention (PCI) with stenting, researchers reported at the American Heart Association’s Scientific Sessions 2008. Results of the Tailored Clopidogrel Loading Dose According to Platelet Reactivity Monitoring to Prevent Stent Thrombosis study were presented as a late-breaking clinical trial.
Full Post: Tailored anti-clotting medications reduce adverse effects after percutaneous coronary intervention
On December 11, 2008, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) - including the Drug Safety & Risk Management Advisory Committee, the Pediatric Advisory Committee, and the Pulmonary-Allergy Drugs Advisory Committee - completed a review of the benefits and risks of asthma medications containing long-acting beta-agonists (LABAs). The committees concluded
Full Post: AstraZeneca responds to FDA advisory committees’ recommendation on SYMBICORT
A stent that entices artery-lining cells to coat it works as well or better than drug-eluting stents in keeping arteries open in coronary heart disease patients, according to two research studies presented at the American Heart Association’s Scientific Sessions 2008. The new endothelial progenitor cell-capturing (EPC) stent is coated with an antibody that binds endothelial
Full Post: Cell-coated stent as effective as drug-coated ones