June 2011 Issues

FDA Says Silicone Gel Breast Implants Remain Safe and Effective, and Issues New ESA Guidelines for CKD -- Bulletin
Summary: In two separate actions this week, the FDA made far-reaching announcements on two products, one a device, the other a drug. And both announcements included new recommendations for doctors and patients.

FDA Advisory Committee Recommends Approval of Regeneron’s AMD Drug -- Quick Pulse
Summary: The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously to recommend approval of Regeneron Pharmaceuticals’ Eylea (aflibercept, VEGF Trap-Eye) for the treatment of neovascular age-related macular degeneration (wet AMD) but only for a 2 mg dose administered every eight weeks.

European League Against Rheumatism (EULAR)
Summary: Use of Human Genome Sciences and GSK’s Benlysta for lupus varies widely, from none at some academic centers to nearly 100% in some private practices with an infusion center. The spoiler may be Immunomedics/ UCB Pharma’s epratuzumab, which could have better efficacy and dosing, and J&J’s sirukumab is far away but subcutaneous. ♦ The market for approved rheumatoid arthritis (RA) drugs is pretty stable, with little payor pressure to use specific biologics. Bristol-Myers Squibb’s Orencia, J&J’s Simponi, and Roche’s Actemra are not picking up much market share. ♦ New oral RA drugs will be used ahead of TNF inhibitors – if they are safe. Pfizer’s tofacitinib continues to show remarkable efficacy, and Pfizer is beginning to address the safety issues, but questions remain. Rigel and AstraZeneca’s fostamatinib looks efficacious and safer than tofacitinib, but patients may not feel as good on it. Lilly’s oral BAFF inhibitor LY-2127399 showed somewhat spotty efficacy, but safety was pretty good, except for some infections. Watch Galapagos’ JAK1 inhibitor. ♦ Doctors are dubious about Crescendo Bioscience’s Vectra DA biomarker blood test for RA. Doctors are enthusiastic about all of the new gout drugs – including Ardea’s lesinurad and Regeneron’s Arcalyst – except that cost may limit use.