November 2008 Issues

FDA Panel Recommends Approval of Takeda’s Gout Drug

Summary: An FDA advisory committee unanimously recommended the FDA approve Takeda’s Uloric (febuxostat) to treat chronic gout – but only if the company is required to do postmarketing safety studies. The panel discussion and FDA comments also made it clear that the FDA will be very sensitive about any safety signals in other gout drugs in development. Thus, it would not be surprising if the FDA requires more safety studies before approving Savient’s Puricase (pegloticase), which was recently submitted to the FDA.

FDA Review of Abuse-Deterrent and Abuse-Resistant Opioids

Summary: Pain Therapeutics/King Pharmaceuticals’ Remoxy XRT (oxycodone CR) got a mixed review from an FDA Advisory Committee which didn’t consider it very abuse-resistant and recommended against an abuse-resistant label if the FDA does approve it. ♦ Alpharma’s abuse-deterrent Embeda (morphine CR + naltrexone) – which will soon belong to King Pharmaceuticals – fared better with the panel. Panel members judged it to be an incremental step forward, making FDA approval likely. ♦ Overall, the FDA remains eager for abuse-resistant or abuse-deterrent formulations of opioids, but the Agency is reluctant to give a product that kind of label. The FDA sought – and got – guidance from the panel on standards for judging these products: studies of more potential abuse methods, more real-world studies, and careful labeling. Another very clear message from the panel: There should be a single risk management program for all opioids, not separate ones for each.

American College of Rheumatology (ACR)

Summary: Rheumatoid arthritis: Bristol-Myers Squibb’s Orencia is picking up market share among the currently approved TNF inhibitors. Rituxan use is holding steady. Of the many new agents on the horizon, rheumatologists are most interested in Roche/Chugai’s Actemra because it has a new method of action (anti-IL-6), but they predicted Johnson & Johnson’s golimumab will be popular with patients because it is once-monthly. The real excitement is over oral small molecules, though they are somewhat further away, there is no clear leader yet, and several have failed. ♦ Gout: Doctors were impressed with the efficacy of Savient Pharmaceuticals’ Puricase for treatment-failure gout and predicted it would have high usage, but questions were raised about its safety and about antibody formation, suggesting the regulatory hurdle may be high. ♦ Osteoarthritis and pain: Pfizer’s tanezumab looks very promising not only for osteoarthritis but also for many other pain-related conditions. ♦ Osteoporosis: Rheumatologists predicted an important role for Amgen’s denosumab, saying the twice-yearly subcutaneous injections are not a barrier to use.