FDA Committee Rejects Expanded Use of Jazz Drug on Abuse Concerns: Biotech's Latest Failures

by: The Burrill Report

A joint advisory committee of the U.S. Food and Drug Administration overwhelmingly voted against the approval of Jazz Pharmaceuticals' (NASDAQ:JAZZ) drug Xyreme for fibromyalgia because of concerns that the risks exceed the benefits. The drug, sodium oxybate, is a central nervous system depressant. It is also known as gamma-hydroxybutyrate or GHB, widely referred to as ‘the date rape drug.” The committee, which voted 20-2 against recommending approval, was concerned about potential abuse of the drug. The drug is currently approved as a treatment for narcolepsy.

The U.S. Food and Drug Administration told Cumberland Pharmaceuticals (NASDAQ:CPIX) that it would need an additional three months to review its drug Acetadote as a treatment for patients with non-acetaminophen acute liver failure. The FDA now expects to act on the company’s application to market the drug in December 2010. Acetadote was launched by Cumberland in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose. In 2006, the FDA approved Acetadote for use in pediatric patients.

Pfizer (NYSE:PFE) said that top line results of a late-stage trial of its cancer drug Sutent in combination with erlotinib versus erlotinib alone failed to show a statistically significant improvement in overall survival of patients with previously treated advanced non-small cell lung cancer, the primary endpoint for the study. The trial, however, showed a statistically significant improvement in progression-free survival, a secondary endpoint of the study. No new or unexpected types of adverse events were observed in the study. Sutent is currently approved for both gastrointestinal stromal tumor and advanced renal cell carcinoma.

Union members at AstraZeneca (NYSE:AZN) plan to accelerate strike action next month over a plan to freeze the company’s pension plan, Associated Press reported. The action will involve three two-hour strikes on September 8, three four-hour strikes on September 15 and a 24-hour strike starting on September 22, the union said in a statement. The strikes follow decisions by AstraZeneca to make what the union called “savage” cuts in its pension plan. About 2,500 workers are affected by the changes, mostly at its facility in northern England. AstraZeneca said the strike is not expected to have a significant impact on the supply of medicines.

The U.S. Food and Drug Administration told EpiCept (OTC:EPCT) that it would not approve the company’s application to market its drug Ceplene to treat patients with acute myeloid leukemia in first remission. Ceplene won approval in the European Union in 2008 and is co-administered with low-dose interleukin-2 (IL-2). The agency said the application failed to establish Ceplene's therapeutic contribution in its combination with IL-2, and recommended that an additional trial to assess Ceplene's contribution and using overall survival as a primary endpoint be conducted.

Genentech (Private:DNA) and its collaborator ImmunoGen (NASDAQ:IMGN) said that the U.S. Food and Drug Administration would not grant accelerated approval to T-DM1. T-DM1 is a version of Genentech’s breast cancer drug Herceptin linked to ImmunoGen’s cancer-cell killing agent DM1. Genentech said it will continue with its ongoing late-stage registrational trial of T-DM1 and continue to work with the FDA. It expects to submit T-DM1 for approval in mid-2012.

The U.S. Food and Drug Administration sent a warning letter to Johnson & Johnson’s (NYSE:JNJ) DePuy Orthopedics unit that it is marketing its TrueMatch Personalized Solution System and its Corail Hip system without required marketing clearance or approval from the agency. The FDA told the company it must cease marketing the Corail Hip system for unapproved uses. It also told the company that it must obtain marketing approval or clearance for the TrueMatch Personalized Solution System, which is used in knee replacements.

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