Approvals In Brief
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Tercica's Increlex measures up: Tercica will launch its extreme short stature therapy Increlex in January with a 30-member sales force following approval Aug. 30 with seven-year orphan drug exclusivity, the firm says. Increlex (mecasermin [rDNA origin]) is labeled for "long-term treatment of growth failure in children with severe primary IGF-1 deficiency (primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH." If and when competitor Insmed's SomatoKine (mecasermin rinfabate) is approved, FDA will decide a battle between the firms for orphan drug exclusivity in the extreme short stature market, Tercica predicts. SomatoKine, which has an Oct. 3 user fee date, is intended to treat growth hormone insensitivity syndrome, an indication encompassed by severe primary IGFD...