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FDA panel backs Takeda obesity drug

An advisory committee to the US Food and Drug Administration has voted in favour of an obesity drug developed by Takeda and Orexigen

An advisory committee to the US Food and Drug Administration (FDA) has voted in favour of marketing approval for an obesity drug being developed by Takeda in partnership with the smaller firm Orexigen Therapeutics. The experimental therapy, known as Contrave, is a combination of naltrexone SR, a marketed drug used to treat alcohol and opioid addiction, and bupropion SR, a marketed drug that treats depression and aids in smoking cessation.

The companies believe the two active ingredients in the experimental obesity drug work together to address both the biological and behavioural causes of obesity.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13-to-7 that the available data adequately demonstrate that the drug's risk-benefit profile is acceptable as a marketed therapy for long-term use in overweight and obese people. The committee also voted 11-to-8 to recommend that the FDA should require a post-approval study evaluating the risk for major adverse cardiac events.

The panel members reached their conclusions based on a review of Orexigen's data for the drug, including four phase III trials in which the co-primary endpoints were the proportion of patients achieving at least 5 per cent weight loss and per cent change in body weight compared to placebo. Secondary endpoints in the trials included multiple measures of cardiometabolic risk, quality of life, control of eating, and glycaemic control.

The FDA is not required to follow the recommendations of its outside advisors, but it often does so. The agency's action date for making a decision on the Contrave marketing application is January 11, 2011.

"We look forward to continued discussions with the FDA regarding the design of a post-marketing study to evaluate cardiovascular risk and to address the questions raised at the meeting,” Michael Narachi, president and CEO of Orexigen, said in a statement following the committee's vote.

Takeda and Orexigen signed their partnership deal on the drug only a few months ago. The exclusive development and commercialisation agreement covers the US, Canada and Mexico. Orexigen received an upfront cash payment of $50m from Takeda, and potentially stands to receive $1bn in milestone payments as well as double-digit royalties.  The company also retains the right to co-promote with Takeda in the US.

The deal calls for the two companies to work together on ongoing development of the product, with Orexigen leading pre-approval activities and Takeda leading post-approval activities.

8th December 2010

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