FDA Green Lights Therapies from Merck & Co., GSK, Baxter, and CSL Behring

The FDA sanctioned Merck & Co.’s type 2 diabetes tablets, the first congenital Protein C deficiency treatment from Baxter, accelerated dosing on GlaxoSmithKline’s (GSK) hepatitis A and B combination vaccine, and CSL Behring’s drug for immune thrombocytopenic purpura (ITP).

Merck & Co. was given the go ahead for a new treatment for type 2 diabetes. Janumet is reportedly the first tablet that combines a dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin, and metformin for the treatment of this disease.

By incorporating the novel mechanism of DPP-4 inhibition with the two active components, sitagliptin and metformin, Janumet has a comprehensive mechanism of action that targets all three key defects of type 2 diabetes for improved glycemic control: diminished insulin release, uncontrolled production of glucose, and insulin resistance, according to Merck.

Janumet has been approved as an adjunct to diet and exercise to improve blood sugar control in adult patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone, or in patients already being treated with the combination of sitagliptin and metformin.

GSK says that it received authorization to accelerate dosing of the only hepatitis A and hepatitis B combination vaccine available in the U.S. The dosing schedule for Twinrix (hepatitis A vaccine (inactivated) and hepatitis B (recombinant) vaccine) now consists of three doses given within three weeks followed by a booster dose at 12 months. The vaccine was first approved for adults in May 2001 on a 0-, 1-, 6-month dosing schedule.

The first therapy for severe congenital Protein C deficiency has been okayed, according to Baxter International. Ceprotin is a plasma-derived Protein C concentrate. It is indicated as a replacement therapy for pediatric and adult patients for the prevention and treatment of venous thrombosis and purpura fulminans.

CSL Behring’s drug to prevent hemolytic disease of the newborn received an addition to its label. Rhophylac Rh(0)(D), an anti-D Rh immunoglobulin is now also indicated for the treatment of ITP. Administered intravenously, Rhophylac is indicated to raise platelet counts in Rh(0)(D)-positive, nonsplenectomized adult patients with chronic ITP.