November 2010 Issues

CMS Backs Provenge Vaccine for Prostate Cancer in FDA-Approved Populations -- Quick Pulse
Summary: The Centers for Medicare and Medicaid Services (CMS) Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) found that Dendreon’s Provenge (sipuleucel-T), a therapeutic vaccine for advanced prostate cancer, showed adequate evidence of an overall survival benefit in patients with asymptomatic or minimally symptomatic metastatic castration-resistant (hormone-refractory) prostate cancer (CRPC). The panel’s average confidence score (on a scale of 1-5, with 5 high) was 3.6.

FDA Panel Recommends Approval of Benlysta for Lupus -- Quick Pulse
Summary: The FDA’s Arthritis Advisory Committee voted 13-2 to recommend approval of Human Genome Sciences’ Benlysta (belimumab), which is being developed in conjunction with GlaxoSmithKline (GSK), for systemic lupus erythematosus (SLE). If the FDA takes the panel’s advice, Benlysta would be the first new treatment for the autoimmune disease in more than half a century. There are only three drugs approved in the U.S. for SLE: aspirin, corticosteroids, and Plaquenil (hydroxychloroquine), an antimalarial drug. However, immunosuppressives are used off-label to treat SLE.

Amercan Society of Nephrology's Renal Week
Summary: ESA use will go down <20% and IV iron use up <15% under CMS’s new bundled reimbursement system. Vitamin D pricing will be under pressure. Home and peritoneal dialysis will stay at ~10% of the market. More frequent conventional dialysis improves survival but is not catching on. ♦ Affymax’s Hematide, a once-monthly erythropoietin mimetic, appears noninferior to EPO in dialysis and non-dialysis CKD patients, but safety is a little worse in the non-dialysis patients. ♦ Nephrologists and patients really like AMAG’s Feraheme, a fast-delivery IV iron, but cost inhibits use. The Mayo Clinic developed a computerized algorithm that maintains hemoglobin in a very tight range while reducing ESA use and holding IV iron use steady. ♦ The SHARP trial found Merck’s Vytorin to be safe in CKD patients, though it did not reduce MI or death or improve renal status. ♦ Reata/Abbott’s bardoxolone methyl, an Nrf2 activator, raises eGFR. If the results hold up in Phase III, this could be a game changer for late-stage CKD patients with Type 2 diabetes. ♦ Alexion’s Solaris was very effective in aHUS.

FDA Meeting on Biosimilar Drugs -- Quick Pulse
Summary: The FDA held a two-day public hearing to receive input on the Biologics Price Competition and Innovation (BPCI) Act of 2009. The legislation, which is part of the Obama administration’s healthcare bill, establishes an abbreviated approval pathway for biological products that are highly similar (biosimilar) or interchangeable with an FDA-licensed biological (made from living cells) product. In other words, the FDA now has the authority to approve biosimilars.