Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has approved a new indication for Micardis (telmisartan) for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from cardiovascular (CV) causes in patients 55 years of age or older at high risk of developing major CV events who are unable to take ACE inhibitors. Micardis is the first treatment in its class to be approved for this indication.
The FDA approval is based upon clinical trial results from The ONTARGET Trial involving 25,620 patients and confirmed Micardis as the only treatment option in its class with proven cardiovascular protective effects in patients with high CV risk. The results also demonstrated that Micardis is better tolerated than the previous gold standard ramipril and associated with higher treatment adherence.
Professor Klaus Dugi, corporate vice president Medical Affairs, Boehringer Ingelheim, commented, “We are delighted with this new indication for Micardis, which will provide both physicians and their patients who are at risk of cardiovascular events with a much needed alternative to ACE inhibitors. Approximately one in four patients are unable to tolerate an ACE inhibitor. Now, these patients can be confident that with Micardis, they have a proven, effective and well tolerated option to reduce their risk of severe CV events.”
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) is currently reviewing a similar submission for Micardis in Europe. The recommendation from the CHMP is expected in November.
Micardis is one of the most studied antihypertensives in clinical trials and is widely used with over five million patient years since its approval. Its safety profile is similar to that of placebo.
Telmisartan is a modern member of the Angiotensin II Receptor Blocker (ARB) class and was investigated in the most ambitious and far-reaching research programme conducted with an ARB. In the clinical trial programmes Ontarget, Protection and PRoFESS, over 58,000 patients were enrolled to investigate the efficacy and cardiovascular protective effects of telmisartan.
Telmisartan was discovered and developed by Boehringer Ingelheim. Under the trademarks Micardis and Micardisplus (combination with hydrochlorothiazide) the company markets telmisartan in 84 countries around the world, including the USA, Japan and European countries. Telmisartan is marketed in cooperation with Astellas Pharma Inc. in Japan, Bayer Schering Pharma in Europe and GlaxoSmithKline in selected markets.
Astellas Pharma Inc. co-promotes telmisartan under the trademark Micardis, Bayer Schering Pharma promotes telmisartan under the brand names Kinzalmono, Kinzalkomb (combination with hydrochlorothiazide), and Pritor and PritorPlus (combination with hydrochlorothiazide) in markets across Europe. Pritor and PritorPlus are also marketed by GlaxoSmithKline in selected markets.