FDA APPROVES TERCICA'S INCRELEX
The FDA has approved biopharmaceutical firm Tercica's human growth hormone therapy Increlex.
The product, which treats short stature caused by severe primary insulin-like growth factor deficiencies (Severe Primary IGFD), also received orphan drug status, Tercica said recently. Orphan drug status, which provides seven years of market exclusivity, is granted to products that treat rare diseases. Severe Primary IGFD affects roughly 6,000 children in the U.S.
Increlex (mecasermin [rDNA origin] injection), which is the only therapy indicated to treat children with Severe Primary IGFD, was approved within a six-month priority review timeline, said John Scarlett, president and CEO of Tercica.
Tercica acquired the rights to Increlex from biotech giant Genentech. The approval occurred over the objections of rival firm Insmed. Tercica and Insmed have been locked in an ongoing battle over their respective growth hormones. Insmed filed a citizen petition with the FDA in August urging the agency to deny approval of Increlex because "Tercica has failed to adequately show the safety of its investigational new drug."