FDA Says Restrictive REMS Plan for Opioid Products Not Imminent

Top drug regulators say it is unlikely the FDA will quickly implement requirements for makers of long-acting and extended-release opioids to have restrictive programs in place for their products. At a meeting convened by the FDA, John Jenkins, director of the FDA's Office of New Drugs, said the agency is "probably going to need additional public input before we would put the program into place." Jenkins also said the FDA would likely convene a special advisory panel later this year to help guide the agency and to review concerns raised at the earlier public and industry meetings.

FDA Panel Backs Genmab's Arzerra in Refractory CLL

An FDA advisory panel has supported approval of Arzerra (ofatumumab), a fully human monoclonal anti-CD20 antibody developed by Genmab AS, of Copenhagen, Denmark, and its partner, London-based GlaxoSmithKline plc, as a treatment for chronic lymphocytic leukemia (CLL) in patients whose disease is refractory to fludarabine and alemtuzumab (Campath, Genzyme Corp.). The firms are seeking an accelerated approval for Arzerra as a single agent to treat patients with CLL.

FDA Wants More Data on ARCA's Heart-Failure Drug

ARCA Biopharma Inc. hopes that earlier amendments to its new drug application - submitted in May but not yet reviewed by the FDA - can help the firm dodge some of the demands in a complete response letter, but for now the fate of the beta-blocker Gencaro (bucindolol) for chronic heart failure is up in the air. A complete response letter from the FDA asks for another efficacy trial, more pharmacology studies to test drug-drug interactions and nonclinical work that would characterize the compound's metabolites.

Advanced Life Sciences Plunges on FDA Panel Vote

Although clinical data showed that Advanced Life Sciences Inc.'s ketolide antibiotic Restanza (cethromycin) is relatively safe, an FDA panel was not convinced it is an effective treatment for mild to moderate community-acquired bacterial pneumonia (CABP). The FDA's Anti-Infective Drugs Advisory Committee voted 11 to 3 that Phase III results demonstrated the safety of Restanza. However, the panel reversed itself when it came to efficacy, voting 11 to 3 that Restanza's data failed to demonstrate efficacy in treating CABP.

Advaxis Denied Orphan Drug Status

The FDA has denied Advaxis Inc. an orphan drug designation application for ADXS1 1-01 (formerly Lovaxin-C) as an immunotherapy for invasive cervical cancer because it failed to meet the agency's criteria of a product intended to treat or prevent a rare disease that affects fewer than 200,000 people in the U.S. The agency grants about 70 percent of the orphan drug designation applications it receives and reached a milestone last month by granting the designation to the 2,000th medical product since the Orphan Drug Act was enacted 26 years ago. Of those that have received the designation, 339 have been approved for the U.S. market.

Still No Winner in Acute HAE; FDA Wants New Cinryze Trial

Another runner has stumbled on a regulatory hurdle in the race to get the first acute hereditary angioedema (HAE) drug to market. In a complete response letter to ViroPharma Inc., the FDA asked for a new trial of Cinryze (C1-esterase inhibitor) in treating acute HAE attacks, citing a lack of robustness in data - but no safety concerns - from the placebo-controlled Phase III trial. Cinryze already has approval as a prophylaxis therapy, but ViroPharma had been hoping to secure the C1 inhibitor market in HAE for itself under the seven-year orphan drug exclusivity rule.