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FDA approval of antihypertensive Prestalia® A codevelopment by Symplmed and Servier26/01/2015
Cincinnati, OH – January 26, 2015 - Symplmed Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) has approved Prestalia® (perindopril arginine and amlodipine) tablets for the treatment of hypertension licensed from Servier (Suresnes, France).
Prestalia® is the first fixed-dose combination of these two medications which may be used as initial therapy. In Europe, Servier has submitted the registration file of this new fixed combination and the process is ongoing.
“This is a significant milestone for Symplmed and for our development partner Servier as it is the first fixed-dose combination including perindopril to receive FDA approval,” said Erik Emerson, President and CEO of Symplmed Pharmaceuticals. “We are excited to be able to provide physicians and patients these two therapeutic classes, ACE inhibitors and calcium channel blockers, in a single pill combination, right from the start of the treatment for hypertension.”
“The burden of hypertension remains very high in all countries and the combination therapy is often the only treatment option for many patients. This new combination of perindopril arginine with amlodipine besylate will definitely contribute to help these patients” said Dr Isabelle Tupinon-Mathieu, Vice-president R&D, Head of the Center for Therapeutic Innovation in Cardiology at Servier.
FDA approval of Prestalia was based on several clinical studies, including the 837-patient Phase III PATH trial (Perindopril Amlodipine for the Treatment of Hypertension) specifically designed for U.S. approval. “We now have another great combination in a single pill of two drugs, each with an evidence-based outcome history,” said George Bakris, MD, former president of the American Society of Hypertension and principal investigator for the PATH trial.
Symplmed Pharmaceuticals is a private pharmaceutical company. The Company’s initial focus is high blood pressure (hypertension) with a proprietary ACE inhibitor ACEON® (perindopril erbumine) and Prestalia®, a single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate. Symplmed also plans to expand its pipeline in multiple therapeutic areas. For more information, visit www.symplmed.com.
Servier is an independent French pharmaceutical research company. Its development is based on the continuous pursuit of innovation in the therapeutic areas of cardiovascular-, metabolic-, neurologic-, psychiatric-, bone- and joint diseases as well as cancer.
In 2014, the company recorded a turnover of 4 billion euros.
92% of Servier drugs are consumed outside of France.
28% of turnover from Servier drugs were reinvested in Research and Development in 2014.
With a strong international presence in 146 countries, Servier employs more than 21 400 people worldwide.
More information is available at: www.servier.com
Servier Communication Department
Tel: +33 1 5572 6037