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Theratechnologies' Drug To Treat Lipodystrophy Gets FDA Approval

Theratechnologies Inc.'s (TH.TO) drug to treat HIV patients with lipodystrophy - Egrifta (tesamorelin), was granted approval by the U.S. Food and Drug Administration on Wednesday.

Egrifta is an analogue of the human growth hormone releasing factor that is administered in a once-daily injection. In May, the FDA Endocrinologic and Metabolic Drugs Advisory Committee had voted 16 to 0 unanimously recommending approval of Egrifta.

The lipodystrophy syndrome, which denotes a number of body shape changes and metabolic problems that can occur in HIV-positive patients, is a common side-effect of anti-retroviral medications that are used to treat HIV.

Lipodystrophy has two forms - fat accumulation (also called lipohypertrophy) and fat loss (also called lipoatrophy). Fat accumulation is generally seen within the belly, behind the neck, around the chin, or in the breasts, while fat loss generally occurs from the arms, legs or face.

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

Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied, the FDA said in a statement.

TH.TO closed Wednesday's regular trading session at C$5 on a volume of 117,500 shares.

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