Boehringer Ingelheim's TWYNSTA approved by FDA for the treatment of hypertension

Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has approved TWYNSTA^®, a new highly effective single pill combination therapy of telmisartan (an angiotensin receptor blocker [ARB]) and amlodipine (a calcium-channel blocker [CCB]). TWYNSTA^® is indicated for the treatment of hypertension, alone or with other antihypertensive agents, and as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

This new combination benefits from the complementary modes of action of long-lasting angiotensin receptor- and calcium channel-blockade. This provides powerful efficacy in 24-hour BP reduction and control and combines it with the proven evidence base in cardiovascular (CV) outcomes of both telmisartan and amlodipine. Telmisartan is the only ARB with proven evidence to reduce CV death, myocardial infarction (heart attack) and stroke beyond the effect of BP reduction in a wide range of patients at risk of CV events. In the US, it is the only ARB indicated for CV risk reduction in patients who are unable to take ACE-inhibitors.

Professor Giuseppe Mancia, Professor of Medicine and Chairman of the Department of Clinical Medicine of the University of Milan, Bicocca, Italy said, “In hypertensive patients, treatment tolerance and compliance are significant issues. The data for this combination of telmisartan and amlodipine show that it is effective and well tolerated in a range of more complex, difficult-to-treat patients as well as in those whose BP was previously not controlled on monotherapy. This combination provides a valuable and important new option for patients and physicians, particularly as it includes two components, telmisartan and amlodipine, each with clinically proven CV protection in patients at CV-risk.”

The FDA approval of TWYNSTA^® is based on the results of one placebo-controlled and two active-controlled trials involving a total of 3,505 patients with stage 1 or stage 2 hypertension. These trials demonstrated that TWYNSTA^® provided powerful BP lowering that was sustained for at least 24-hours, and was also effective and well-tolerated in hypertensive patients at risk of CV events, including patients with Type 2 diabetes, elderly and obese patients.

Professor Klaus Dugi, Corporate Vice President Medical Affairs, Boehringer Ingelheim, commented, “We are delighted with the approval of TWYNSTA^® and believe that, with its excellent safety profile and demonstrated efficacy, TWYNSTA^® will help physicians and patients to overcome common barriers to effective blood pressure control, such as treatment adherence.”

TWYNSTA^® will be available in the US from November 2009 in a flexible range of dosing regimens (40/5mg, 40/10mg, 80/5mg, 80/10mg) enabling physicians to tailor treatment to individual patient needs.

TWYNSTA^® has recently also been submitted for approval in Europe and Japan, and is on schedule to be submitted in other countries around the world. Boehringer Ingelheim is committed to make this valuable new therapeutic option available to patients and health care providers as soon as possible after Marketing Authorisation approval is obtained.