FDA accepts NDA Prestalia Symplmed for the treatment of hypertension -
Symplmed announced today that the US Food and Drug Administration (FDA) agreed to review its new drug application (NDA) for the investigational medicinal Prestalia ® , the first single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate for the treatment of hypertension in the United States Symplmed filed the application under section 505 (b) (2) according to the FDA guidance. The Act on prescription drug costs (PDUFA) goal date for Prestalia is January 21, 2015.
Perindopril is known, long-converting enzyme Action (IEC) reported for hypertension and stable coronary artery disease. Amlodipine, antihypertensive a prescribed number, is a calcium channel blocker is indicated for the treatment of hypertension and coronary artery disease. Servier, a French company first pharmaceutically private research and development partner to Symplmed currently sells a single tablet combination therapy Coveram ® in 84 countries outside the United States. Prestalia is the first and only single tablet, fixed-dose combination of these two important drugs to be considered by the FDA to date.
"The acceptance of our NDA is a significant milestone for the company Symplmed Prestalia that will be our first patented product with regulatory exclusivity," said Erik Emerson, President and CEO of Symplmed. "The Phase III data showed that Prestalia provided a quick and sustained blood pressure control in one pill. We look forward to working with the FDA throughout the review process."
The Prestalia NDA is mainly supported by data from the 837 -Patient test PATH Phase III ( P erindopril A mlodipine for reatment T of H ypertension) which demonstrated that the single pill perindopril arginine combined with amlodipine besylate was significantly better than either compound alone in reducing both sitting diastolic and seated systolic blood pressure after six weeks of treatment.
"clinical study results suggest that PATH Phase III Prestalia could provide an effective and practical option for patients," said George L. Bakris, MD, past president of the American Society of Hypertension and principal investigator of the PATH test. "the clinical study also indicated that the combination may provide a better risk / benefit ratio may be the only treatment. A single tablet, fixed-dose combination of perindopril arginine and amlodipine besylate is a welcome addition to our treatment options "
DyrctAxess. The next step in optimizing care
If approved, Symplmed Prestalia offer via its own web portal, DyrctAxess as part of an overall hypertension management offer approach. Symplmed revolutionizes the process in which savings -Life and drugs that promote health are obtained from its own growth pipeline, as well as industry partners. DyrctAxess unifies all elements of the prescription process, including adjudication, execution, compliance and monitoring results. the portal offers increased efficiency, control and information to empower patients, physicians and payers and contribute to achieving optimal care.
EmoticonEmoticon