Egrifta tesamorelin regulatory update
Theratechnologies said it and partner Actelion Ltd. (SIX:ATLN, Allschwil, Switzerland) responded to questions contained in a notice of non-compliance from Health Canada for an NDS for tesamorelin to treat excess abdominal fat in HIV-infected patients with lipodystrophy. The notice contained questions on the long-term safety of tesamorelin, the appropriate patient population and the proposed indication. Theratechnologies expects a decision on the application within 150 days.
Additionally, Theratechnologies said it and its Latin American marketing partner, Sanofi (Euronext:SAN; NYSE:SNY, Paris, France), addressed all technical deficiencies identified by Brazil's National Health Surveillance Agency identified at a third-party tesamorelin manufacturing site in Montreal. The final manufacturing assessment must be made by the Brazilian agency. ...