The Committee for Medicinal Products for Human Use’s (CHMP’s) positive opinion will now be considered by the European Commission, which is expected to issue a final decision regarding marketing approval for Thelin within approximately 90 days.
Under the EMEA’s centralized licensing procedure, if approved, Encysive would be granted marketing authorization for Thelin in all 25 member states of the European Union.
Efficacy of the drug has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease.
Pulmonary arterial hypertension (PAH) is a condition that involves high blood pressure and structural changes in the walls of the pulmonary arteries – the blood vessels that connect the right side of the heart to the lungs.
PAH causes shortness of breath, limits activity, and is eventually fatal unless treated successfully with heart/lung or lung transplantation. PAH is estimated to afflict approximately 100,000 to 200,000 people worldwide, many of whom are children and young women.