New FDA Approvals

The Food and Drug Administration recently announced the following approvals: • FDA has approved Gilead Sciences' Letairis (ambrisentan) for treating pulmonary arterial hypertension. Letairis, a new drug not previously approved in the U.S., was granted a priority review, meaning FDA had a six-month target date for a decision.

The agency said the drug's safety and effectiveness were demonstrated in two international clinical trials involving 393 patients. Letairis significantly improved physical activity capacity compared with a placebo, as shown by a six-minute walk, FDA said. Letairis also delayed the worsening of the pulmonary hypertension. The most common side effects in using Letairis included swelling of legs and ankles, nasal congestion, sinusitis, and facial flushing.