Actelion wins crucial FDA approval for next-gen lung disease drug Opsumit

New Drug Approvals

File:Macitentan skeletal.svg


N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N’-propylsulfamide, CAS NO  441798-33-0

October 18, 2013 | By John Carroll

Late on Friday the FDA came through with an approval for Actelion’s pulmonary arterial hypertension (PAH) drug Opsumit (macitentan), its next-gen successor to the franchise drug Tracleer.

Read more: Actelion wins crucial FDA approval for next-gen lung disease drug Opsumit – FierceBiotech
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Macitentan (Opsumit® )is a novel dual endothelin receptor antagonist that resulted from a tailored drug discovery process. Macitentan has a number of potentially key beneficial characteristics – i.e., increased in vivo preclinical efficacy vs. existing ERAs resulting from sustained receptor binding and tissue penetration properties. A clinical pharmacology program indicated a low propensity of macitentan for drug-drug interactions.

Macitentan is an investigational drug being studied for the treatment of pulmonary arterial hypertension. It acts as a dualendothelin receptor antagonist and is being developed…

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