ARTICLE | Company News

Genentech, Insmed, Tercica endocrine news

August 22, 2005 7:00 AM UTC

TRCA said a Citizen Petition that INSM submitted to FDA contains inaccurate statements and incorrect assumptions. The petition asks FDA to deny approval of TRCA's NDA for Increlex mecasermin, a recombinant human IGF-1 protein ( rhIGF-1), to treat children with a severe form of primary insulin-like growth factor-1 deficiency (IGFD). The NDA has an Aug. 31 PDUFA date. TRCA and INSM declined to comment on specific aspects of the petition.

In the petition, INSM "believes Tercica's NDA does not include data that adequately ascertain and document the risk of hypoglycemia and other serious adverse events" associated with rhIGF-1. The petition alleges that TRCA's "'full reports of investigations' of the safety and efficacy of Increlex are largely based on a retrospective analysis of data collected from a 'compassionate use program' with rhIGF-I in GHIS." INSM asserted that compassionate use programs typically "are not designed to provide rigorous evidence of the safety of a drug" and tend to underreport adverse events. The company also questioned whether a study in GHIS can be extended to the larger population of IGFD patients. ...