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Article: Insmed's Growth Hormone Approvable; 'Issues' Remain.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Staff Writer
The FDA issued an approvable letter for iPlex, a growth hormone deficiency drug from Insmed Inc., less than a month after the product's chief competitor, Tercica Inc.'s Increlex, gained the agency's blessing for the same indication.
Formerly known as SomatoKine, iPlex (rhIGF-1/rhIGFBP-3) (mecasermin rinfibate) is indicated for the treatment of children with growth failure who suffer from severe primary insulin-like growth factor-1 (IGF-1) deficiency. On the positive side, the approvable letter does not ask for any additional clinical studies, and requests only for clarifications that are "pretty minor in nature," regarding chemistry, ...