Insmed's Iplex approved by FDA for growth failure in children

New York, Dec. 12 - Insmed Inc. said the Food and Drug Administration approved its Iplex (mecasermin rinfabate (rDNA origin) injection) for the treatment of growth failure in children with severe primary IGF-1 deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone.

Iplex is an orphan drug and so is entitled to seven years of marketing exclusivity for the treatment of primary IGF-1 deficiency.

"We are very pleased Iplex was approved, making Iplex the only approved once-daily IGF-1 replacement therapy available to treat children with severe short stature," said Geoffrey Allan, president and chief executive officer of Insmed, in a news release.

"Today marks the beginning of a new treatment paradigm for treating children with Primary IGFD."

He added that Insmed expects to launch Iplex in the second quarter of 2006.

Insmed is a Richmond, Va., biopharmaceutical company.

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