Theratechnologies (TH.TO) on Tuesday said the U.S. Food and Drug Administration (FDA) has approved EGRIFTA SV, or tesamorelin, for injection for release.
EGRIFTA SV is the only treatment approved in the U.S. to reduce excess abdominal fat in adults with HIV and lipodystrophy. The latest approval removes any regulatory requirement for product release, allowing Theratechnologies to resume regular distribution of EGRIFTA SV. The FDA recently approved the new F8 formulation of tesamorelin for injection, which is set to replace EGRIFTA SV and will be marketed in the US as EGRIFTA WR, the company said.
"Securing FDA approval. . . closes a chapter of supply uncertainty and we are pleased to return to normal supply conditions," said Paul Levesque, Theratechnologies chief executive. "Now that we have also obtained approval of EGRIFTA WR, we look forward to transitioning patients to this more convenient formulation, which we have designed to improve the patient experience."
The company's shares were last seen up US$0.02, to US$1.66, in New York pre-market trading.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.