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Opsumit - PAH Drug Bags FDA Approval
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The long awaited approval by Actelion pharmaceutical for its pulmonary Arterial Hypertension drug (PAH), Opsumit is sanctioned by FDA.

Actelion Pharmaceuticals filed its first application with FDA seeking approval for its drug Opsumit (Macitentan) on 22nd October 2012 and received the FDA’s acceptance of the application in December 2012. Following this sequence of procedures, Actelion got the approval from FDA for Opsumit on 18th October, 2013 which had an impact of 7% rise in its shares. The 14 years of untiring effort by Actelion towards drug discovery for Pulmonary Arterial Hypertension reaped its success by FDA’s approval for Opsumit.

Pulmonary Arterial Hypertension is a condition indicated with a pulmonary arterial pressure increasing above 25 mm Hg when the individual is at rest and above 30 mm Hg with physical activity. The blood flows from the heart to the lungs through pulmonary arteries and in case of pulmonary arterial hypertension, the blood vessels thickens in the lungs restricting the blood flow from heart to the lungs resulting in the increased pressure in the lungs. The severe condition of PAH requires lung transplantation or it could be fatal.

Actelion pharmaceutical proudly presents the endothelin receptor blocker drug Opsumit which reduces the blood pressure in the lungs by relaxing the pulmonary arteries and also claims Opsumit as an effective oral drug to treat people with pulmonary arterial hypertension. The cost of this drug is almost similar to its predecessor drug Tracleer.

Actelion warns the use of this drug in pregnant women as it may affect the fetus and also ensures the safe use of this drug on female patients through a program called Opsumit Risk Evaluation and Mitigation Strategy (REMS). This program demands practitioners prescribing this drugs and pharmacists supplying this drug to be certified through this program thus ensuring the safety of the drug. Some of the side effects of Opsumit are decline in RBC, common cold and flu, bronchitis and UTI.

The entry of Opsumit into the drug market is of greater importance to the patients treated for PAH, as this drug is known to delay the progression of the disease.
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