FDA Actions in Brief March 2012 (Corcept Therapeutics, Merck, Amylin Pharmaceuticals, Alkermes, Sanofi, Mobius Therapeutics, Vertex Pharmaceuticals, Boehringer Ingelheim, Eli Lilly, Pfizer, UCB, Curis, Genentech, Novartis)

March 1, 2012

Recent FDA Approvals (through February 2012) related to (Corcept Therapeutics, Merck, Amylin Pharmaceuticals, Alkermes, Sanofi, Mobius Therapeutics, Vertex Pharmaceuticals, Boehringer Ingelheim, Eli Lilly, Pfizer, UCB, Curis, Genentech, Novartis)

Mifepristone (Korlym, Corcept Therapeutics) was approved to control high blood sugar levels in adults with endogenous Cushing's syndrome who have type 2 diabetes or glucose intolerance and are not good candidates for surgery or who have not responded to prior surgery.

Tafluprost ophthalmic solution (Zioptan, Merck) 0.0015%, the first preservative-free prostaglandin, was approved for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Exenatide extended-release for injectable suspension (Bydureon, Amylin and Alkermes) was approved for once-weekly treatment for type 2 diabetes.

Mitomycin for solution (Mitosol, Mobius Therapeutics) was approved for use in glaucoma surgery.

Ivacaftor (Kalydeco, Vertex Pharmaceuticals) was approved for the treatment of a rare form of cystic fibrosis in patients age 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator gene.

Linagliptin/metformin hydrochloride (Jentadueto, Boehringer Ingelheim and Eli Lilly) tablets were approved for the treatment of adult patients with type 2 diabetes.

Axitinib (Inlyta, Pfizer) was approved to treat patients with renal cell carcinoma who have not responded to another drug for this type of cancer.

An expanded indication for levetiracetam (Keppra, UCB) tablets and oral solution was approved as adjunctive therapy in the treatment of partial onset seizures in adults and children age 4 years and older with epilepsy.

Vismodegib (Erivedge, Curis and Genentech, a member of the Roche Group) was approved for the treatment of adult patients with basal cell carcinoma. It is the first FDA-approved drug for metastatic basal cell carcinoma.

The imatinib mesylate (Gleevec, Novartis) label was updated to recommend 36 months of treatment after surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST) who met the risk of recurrence inclusion criteria of the pivotal trial. This treatment regimen has been shown to improve recurrence-free survival (RFS) and overall survival (OS) for KIT+ GIST patients compared with 12 months of treatment.

Sitagliptin and metformin hydrochloride (HCl) extended-release (Janumet XR, Merck) tablets were approved for the treatment of type 2 diabetes. The combination therapy consists of sitagliptin, which is the active component of Januvia, and extended-release metformin.