FDA at it again and more trouble for MannKind

FDA at it again and more trouble for MannKind

So much for the FDA changing the way they do business as they have once again have wreaked havoc with yet another complete response letter. This time the letter went to Orexigen (NASDAQ:OREX) who was awaiting approval of their weight loss drug Contrave®. According to a company issued press release;

“The FDA noted concern about the cardiovascular safety profile of naltrexone/bupropion when used long-term in a population of overweight and obese subjects. Specifically, the letter stated that “before your application can be approved, you must conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with naltrexone/bupropion does not adversely affect the drug’s benefit-risk profile.”

Not surprisingly shares of Orexigen are plunging on the news down more than 70%.

This news is also not good for another company with FDA issues as MannKind (NASDAQ:MNKD) is now facing a shareholder lawsuit. According to a press release;

“Robbins Geller Rudman & Dowd LLP (“Robbins Geller”) (http://www.rgrdlaw.com/cases/mannkind/) today announced that a class action has been commenced in the United States District Court for the Central District of California on behalf of purchasers of MannKind Corporation (“MannKind”) (NASDAQ:MNKDNews) common stock during the period between June 25, 2010 and January 19, 2011 (the “Class Period”).”

MannKind shares continue to fall and given the way things are going there may be nothing left to collect if these shareholders win their lawsuit.