Canada's Theratechnologies took a big step forward on Thursday, winning the unanimous backing of 16 FDA panel members who recommended its new HIV drug tesamorelin for approval.
Designed to treat the excess build-up of abdominal fat, the fate of tesamorelin now moves to the agency, which has set a July 27 deadline for a final decision. The FDA isn't bound by the recommendation, but the agency is unlikely to ignore a unanimous vote in its favor.
"The advisory committee's recommendation is especially significant for those patients who suffer from this serious metabolic complication where today no treatment option exists," says Theratechnologies CEO Yves Rosconi. "It's also an important step forward for the company...it has taken 15 years to reach this outcome."
In the fall of 2008, Theratechnologies inked a $215 million licensing pact for tesamorelin with EMD Serono covering the U.S. market. The developer gained $30 million upfront in the deal, which will also generate royalties for the company.
- here's the press release
- here's the story from the Montreal Gazette