October 2010 Issues

Transcatheter Cardiovascular Therapeutics (TCT) -- Quick Pulse
Summary: Positive one-year data from the randomized, controlled PARTNER trial of Edwards Lifesciences’ Sapien percutaneous aortic valve was the biggest news at TCT, with investigators calling 2010 the “Year of the Valve.”

FDA North American Cystic Fibrosis Conference
Summary: Doctors are optimistic about the outlook for Vertex’s VX-770 in the small group of G551D CF patients. ♦ Vertex’s VX-809 showed only a small effect on sweat chloride in a Phase II trial in F508del CF patients, so doctors are cautiously enthusiastic about combination therapy with VX-770 + VX-809 in F508del. ♦ Inspire’s denufosol missed its primary endpoint in a Phase III subanalysis, but doctors are fairly optimistic because the effect increases with longer duration of therapy. ♦ Use of Gilead’s Cayston, an inhaled antibiotic, is increasing at the expense of Novartis’s Tobi, at least until Novartis gets approval for its dry powder Tobi. And three new inhaled antibiotics on the horizon appear promising – Aradigm’s ARD-3150, Gilead’s fosfomycin/ tobramycin combination, and Transave’s Arikace. ♦ Pharmaxis’ Bronchitol (inhaled mannitol) missed the primary endpoint in a Phase III trial, but the company still plans to seek approval in the U.S. and Europe.

FDA Advisory Panel Recommends Approval of Warfarin Alternative -- Quick Pulse
Summary: The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously (9-0) to recommend approval of Boehringer Ingelheim’s anticoagulant Pradaxa (dabigatran etexilate) for the prevention of stroke in atrial fibrillation patients. Pradaxa is intended as a replacement or alternative to Coumadin (warfarin), which requires dose adjustments and monitoring and has interactions with food and other drugs. The panel recommended that both doses of Pradaxa (110 mg and 150 mg) be approved. The FDA is expected to decide on the drug by October 19, 2010.

FDA Advisory Committee Rejects Another Diet Drug: Arena's Lorqess -- Quick Pulse
Summary: The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee rejected Arena Pharmaceuticals/Eisai’s diet drug Lorqess (lorcaserin), voting 9 to 5 that the benefits do not outweigh the risks. While the drug’s efficacy was viewed as marginal, it met the FDA criteria for approval, but the issue was safety. The panel was concerned with heart valve safety and carcinogenicity; depression, suicidality, and cognitive disorders were less of a concern but still cast a shadow over the drug.

Abbot's Diet Drug Meridia Taken Off Market -- Quick Pulse
Summary: At the request of the FDA, Abbott is voluntarily withdrawing Meridia from the U.S. market because of data from the European SCOUT trial which found an increased risk of heart attack and stroke. In making the announcement, Dr. John Jenkins, director of the FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (CDER), said, “Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke. Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their healthcare provider about alternative weight loss and weight loss maintenance programs.”