MONTREAL — Theratechnologies says it will receive a US$10-million milestone payment from EMD Serono Inc. after the U.S. Food and Drug Administration agreed to review documents for its tesamorelin drug. Theratechnologies emphasized that at this point the FDA has not accepted the company’s application, but has only agreed to look at the tesamorelin file. But the decision marks another step towards the company’s goal of getting approval for the drug, which is aimed at treating HIV-associated lipodystrophy. EMD had agreed to make specific payments when the Montreal-based drug developer reached certain goals. From here, the company will begin a substantive review of the application, which was submitted to the FDA on May 29.
