BioCentury
ARTICLE | Clinical News

VRS-317: Phase III ongoing

July 27, 2015 7:00 AM UTC

Versartis will resume enrolling U.S. patients in the open-label, international Phase III VELOCITY trial after FDA lifted a partial clinical hold on VRS-317. The company said it had submitted additional bioanalytical data to FDA and noted the agency did not request data related to safety concerns, efficacy or formulation. VELOCITY is comparing 3.5 mg/kg subcutaneous VRS-317 twice monthly vs. subcutaneous rhGH once daily for 1 year in up to 136 treatment-naive patients ages 3-11. ...