FDA actions

FDA actions

The FDA has approved linagliptin for the treatment of type 2 diabetes in adults. The drug is an inhibitor of DPP-4, an enzyme that degrades incretin hormones (GLP-1 and GIP). It is approved for use as a stand-alone therapy or in combination with other drugs for type 2 diabetes including metformin. The approval was based on eight double-blind, placebo-controlled trials of nearly 4000 patients that showed improved blood glucose control compared to placebo. Linagliptin is marketed by Boehringer Ingelheim Pharmaceuticals as Tradjenta.

The FDA has approved rilpivirine, a new non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of adults with HIV-1 infections who are treatment naïve. Rilpivirine is to be used as part of a highly active antiretroviral therapy (HAART). The approval was based on two phase 3 trials of nearly 1400 adults with HIV who were observed for 48 weeks, and an additional 96-week trial in which the drug was compared to efavirenz as part of multidrug combinations. Rilpivirine was found to be comparable to efavirenz with regard to percentage of patients with undetectable HIV viral load. Patients who failed rilpivirine are more likely to develop drug resistance than patients who failed efavirenz. Rilpivirine is marketed by Tibotec Therapeutics as Edurant.

Rosiglitazone (Avandia) remains on the U.S. market, but its days may be numbered. In a new step to restrict use of the drug, the FDA has updated the Risk Evaluation and Mitigation Strategy to include a restricted access in distribution plan. Physicians and patients must enroll in the distribution program in order to receive the drug. Rosiglitazone will no longer be available in commercial pharmacies after mid-November and will only be available by mail order through certified pharmacies. Use of the drug is limited to patients who are currently on rosiglitazone and whose diabetes is not controlled by other treatments and who are unwilling to change to pioglitazone (Actos).