Johnson and Johnson announces FDA approval for new drug application for Opsumit

recently, Actelion http://
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s (http:// jndJ),announced that the http://application for theof the new
drug (http:// of The http:// had received a complete response letter (CRL) from theFDA(http://the sNDA application approved Opsumit for use in adult patients with chronic thrombosis pulmonary hypertension (CTEPH, WHO Grade 4) for surgery that cannot be cured, improving pulmonary vascular resistance (PVR) and motor abilityTHE CRL CONTENT INDICATES THAT ADDITIONAL DATA IS NEEDED TO EVALUATE OPSUMIT'S USE IN THE TREATMENT OF CTEPHOpsumit's new application for treatment of CTEPH is based on data from Phase II clinical studies MERIT-1The study assessed the efficacy, safety, and tolerability of adult patients whose 10 mg dose of Opsumit surgery was incurable in adult patients with CTEPH (WHO Grade 4)The data for the study was published in The Lancet Respiratory MedicineOpsumit
Opsumit is a dual-acting endothelial receptor antagonist (ERA) that relaxes the pulmonary arteries and lowers blood pressure, and has been approved in the United States and the European Union for treatment of pulmonary hypertension (PAH, WHO Grade 1) to reduce the risk of PAH disease progression and hospitalizationOpsumit, like otherdrugs of its kind,(http://has a black-box warning that the embryo/fetal toxicity isFor female patients, Opsumit treatment is available through a restricted program called the Opsumit Risk Assessment and Mitigation Strategy (REMS)In September 2018, Opsumit's first Phase III clinical study of the treatment of pulmonary hypertension (PoPH) was successfulThe results showed that after 12 weeks of treatment, Opsumit significantly improved pulmonary vascular resistance (PVR) compared to placebo, reaching the main endpoint of the studyPoPH is a subset of pulmonary hypertension (PAH) and is associated with high pressure in the door vein (elevated blood pressure in the venous), usually caused by cirrhosis of the livercurrently, PoPH is increasingly recognized and there is evidence that it is the fourth most common type of PAHIn many cases, PoPH patients are only diagnosed as a result of liver transplant evaluationHowever, severe PAH is contraindicated for liver transplantation due to poor surgical prognosis