FDA Approves New Use for Micardis® in Cardiovascular Risk

FDA Approves MICARDIS® (Telmisartan) As the First Treatment in its Class to Reduce the Risk of Heart Attack, Stroke, or Death from Cardiovascular Causes...

 

FDA Approves MICARDIS® (Telmisartan) As the First Treatment in its Class to Reduce the Risk of Heart Attack, Stroke, or Death from Cardiovascular Causes in Patients at High Cardiovascular Risk Who Are Unable to Take ACE Inhibitors

 

MICARDIS® is now indicated for cardiovascular (CV) risk reduction in patients who are unable to take angiotensin-converting enzyme (ACE) inhibitors

 

* Boehringer Ingelheim`s MICARDIS® (telmisartan) is the ONLY treatment in its class approved by the US Food and Drug Administration (FDA) in patients at high CV risk who are unable to take ACE inhibitors

 

* MICARDIS® is the first indicated treatment option in its class to prevent serious CV events in patients at high CV risk who are unable to take ACE inhibitors

 

* This new indication is based on The ONTARGET Trial results which showed that MICARDIS® may prevent one in five serious CV events or death from cardiac causes.

 

INGELHEIM, Germany--(Business Wire)--

Boehringer Ingelheim announced today 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."

 

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