FDA approves Boehringers ARB for new indications

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The FDA has approved Boehringer Ingelheim Pharmaceuticals’ supplemental new drug application (NDA) for its angiotensin II receptor blocker (ARB) Micardis (telmisartan) tablets 80 mg for reduction of the risk of MI, stroke or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events, who are unable to take angiotensin-converting enzyme (ACE) inhibitors.

Micardis has been studied in this high-risk patient population and has been commercially available to treat hypertension since its approval in 1998.

The Ridgefield, Conn.-based company said that the FDA also approved an NDA for its combination agent Twynsta (telmisartan/amlodipine) tablets for the treatment of hypertension alone or in combination with other anti-hypertensive agents, or as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals.

Twynsta combines the complementary blood pressure lowering effects of telmisartan, the active ingredient in Micardis, with the calcium channel blocker amlodipine. Twynsta is not indicated for cardiovascular risk reduction. The new medicine will be available in pharmacies in November in the following strengths: 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg.