Montreal-based Theratechnologies drug, Egrifta, which helps in lessening surplus abdominal fat in HIV-infected patients with lipodystrophy, was voted 16-0 by U. S. Food and Drug Administration committee.
But on Thursday, FDA granted approval for marketing the drug. FDA said that the drug might increase the risk of diabetes. But that doesn't mean the agency will torpedo the drug's approval during a hearing scheduled for today.
As a result, the shares of Theratechnologies shot up 85 per cent in early Friday trading.
"We remain confident that Egrifta's suite of features and benefits outweighs modest impact on diabetes incidence in some patients," Mr. Loe wrote. "[That said,] we now expect that the FDA could put label restrictions on Egrifta, excluding diabetic and prediabetic HIV patients from being eligible for therapy".
The drug is especially significant for those patients who suffer from this serious metabolic complication, where today no treatment option exists.
The advisory committee recommendation is very important for the Company at this time and there is a reasonable probability that they will also give drug's approval.
Theratechnologies expects the FDA will complete its review of the new drug application by July 27.