Guideline: Extended Survival Is Endpoint in PAH Trials

Sponsors of pulmonary arterial hypertension (PAH) drug trials should consider goals that prolong patient survival, reduce morbidity, ease symptoms and improve quality of life, a European Medicines Agency (EMEA) draft guideline says. Sponsors have been proving the efficacy of PAH drugs mainly by demonstrating improvement in the patients’ exercise capacity, using a six-minute walking test. The EMEA recommends a composite primary endpoint that combines the exercise test with other efficacy endpoints to show a treatment slows or halts clinical progression of the disease.
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