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FDA Extends Review Of Theratechnologies' Tesamorelin

Theratechnologies (TH.TO) said it now expects to have an official response from the FDA regarding the timeline to review tesamorelin's new drug application in the fourth quarter of 2010. Earlier, the FDA had set July 27 as action date for tesamorelin.

Tesamorelin, whose brand name is Egrifta, is an analogue of the human growth hormone releasing factor. The company is seeking FDA approval for Egrifta for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.

There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy.

In its feedback, the FDA has indicated that the review is progressing well, the company said. The company said it is continuing discussions with the FDA regarding the regulatory process for tesamorelin.

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