August 2010 Issues

FDA Advisory Committee Recommends Either Serious Restrictions on Use of Withdrawal of GSK's Avandia -- Quick Pulse
Summary: After spending two days hearing from a long list of experts, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, meeting jointly, voted that concerns over the cardiovascular (CV) safety of GlaxoSmithKline’s diabetes drug Avandia (rosiglitazone), a thiazolidinedione (TZD), were serious enough that the drug either should have its use restricted or be withdrawn from the market.

FDA Proposes Changes to 510(k) Program for Medical Device Approvals -- Quick Pulse
Summary: Saying it wants to accomplish three goals − fostering device innovation, creating a more predictable regulatory environment, and enhancing device safety − the FDA on August 3, 2010, issued preliminary recommendations for changes relating to the 510(k) program under which many medical devices are approved. These proposed changes, which come after multiple public and internal meetings, will be open for public comment for 60 days. After reviewing the public comments, the FDA will announce which improvements it plans to implement and the timeline
for that implementation.

FDA Advisory Committee Recommends Approval of Glaukos' iStent -- Quick Pulse
Summary: Although panel members had mixed feelings about the data, the FDA's Ophthalmic Devices Advisory Committee voted overwhelmingly to recommend approval of Glaukos' iStent Trabecular Micro-Bypass Stent in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in patients with mild-to-moderate open-angle glaucoma. Panel members agreed that the FDA analyses showed that the iStent has limited efficacy, but they appeared to be swayed by the glaucoma specialists who wanted another tool for their toolbox.

European League Against Rheumatism
Summary: Osteoarthritis (OA). Pfizer's nerve growth factor tanezumab is on clinical hold due to osteonecrosis resulting in joint surgery, and the outlook for resumption doesn't look promising. The neuropathic side effects are also concerning. ♦ Rheumatoid arthritis (RA). The economy is starting to have a chilling effect on the use of approved biologics in RA. In this environment, the newer biologics are gaining market share very slowly, even with discount offers. The excitement in RA is over the new oral drugs in development − the JAK and Syk inhibitors − which doctors think will dramatically change the way patients are treated when they are available. While the oral agents are very exciting, there is a concern that there will be unwanted side effects, and there is still no radiographic data. ♦ Lupus. Rheumatologists are also very excited about Human Genome Sciences. Benlysta (belimumab) for lupus, and most believe the benefit, though small, is clinically meaningful. They predicted that 15%-43% of lupus patients will be eligible, with up to half of these taking the drug . at least for one year. Cost will be the big limiting factor. ♦ Gout. Ardea's RDEA-594 looks promising, either alone or in combination with allopurinol. Safety appears good, but doctors want to see Phase III safety data.

FDA Guidance for Industry on Self-Induced Liver Injury -- Quick Pulse
Summary: Three FDA officials, speaking on a recent Drug Information Agency webinar, discussed the FDA.s guidance on drug-induced liver injury (DILI). The guidance was published in July 2009, but the Agency saw a need to further explain the guidance to industry. The comments, which were intended to help industry in applying the guidelines, also may be useful in interpreting liver issues in clinical trials.