FDA Approves First in New Class of Hypertension Drugs

The FDA yesterday approved Tekturna (aliskiren), the first antihypertensive drug that works by directly inhibiting renin.

In clinical trials, Tekturna was shown to be effective in patients with mild-to-moderate hypertension, with slightly smaller blood pressure reductions for African Americans than for Caucasians and Asians. The drug's safety was assessed in almost 6500 patients, the FDA said; side effects were typically mild and brief, though rare allergic reactions were observed, and the drug is contraindicated in pregnancy.

The manufacturer expects the drug to be available this month as once-daily 150 mg and 300 mg tablets. It plans to conduct large outcome trials to evaluate the drug's long-term effects.