FDA asks Insmed for more data on growth therapy
Tue Sep 27, 2005 07:26 PM ET
SAN FRANCISCO, Sept 27 (Reuters) - Insmed Inc. (INSM.O: Quote, Profile, Research) on Tuesday said the U.S. Food and Drug Administration had asked for more data before the agency clears the company to apply for final approval on a growth therapy for children.
In a statement, the company said was asked for more data on iPlex (rhIGF-I/rhIGFBP-3) (Mecasermin rinfibate), for the treatment of children with growth failure who suffer from Severe Primary IGF-1 deficiency.
The FDA is not requiring the company to conduct additional preclinical or clinical trials. The U.S. agency has informed Insmed that they are still considering iPlex's orphan exclusivity status, the company said.
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