BioCentury
ARTICLE | Clinical News

Egrifta tesamorelin regulatory update

November 11, 2013 8:00 AM UTC

Theratechnologies announced that Health Canada agreed to resume review of an NDS for Egrifta tesamorelin to treat excess abdominal fat in HIV-infected patients with lipodystrophy. In March, the application received a notice of non-compliance-withdrawal (NON/w), which concluded the risks of tesamorelin outweighed its benefits. The biotech said the decision to rescind the NON/w was based on recommendations contained in a report issued by a reconsideration panel. The review of Egrifta will resume at the same stage as it was before the issuance of the notice (see BioCentury, March 18, April 1 & July 22). ...