ARTICLE | Clinical News

HyQvia regulatory update

April 23, 2012 7:00 AM UTC

Halozyme and partner Baxter said FDA needs additional information before the agency can complete the review of HyQvia for primary immunodeficiency disorder. According to the partners, FDA requested additional data - either from clinical or preclinical studies - on the long-term use of HyQvia, but did not issue a complete response letter. The partners expect to discuss the agency's request at a meeting of FDA's Blood Products Advisory Committee, which has yet to be scheduled. A decision on the BLA was expected this quarter, with a launch slated for next half. The companies said the expected launch could be delayed beyond 2012, but did not provide details. ...