Posted by Michael Wonder on 19 Oct 2017
Teva announces submission of biologics license application for fremanezumab to the U.S. FDA
17 October 2017 - Key milestone reached for Teva to advance global fremanezumab program for the preventive treatment of migraine.
Teva Pharmaceutical Industries today announced the submission of a biologics license application to the U.S. FDA for fremanezumab, an anti-calcitonin gene-related peptide monoclonal antibody for the preventive treatment of migraine.
The application includes data from the HALO clinical trial program, which enrolled more than 2,000 patients with episodic migraine and chronic migraine, evaluating both monthly and quarterly dose regimens of fremanezumab. Results from these trials were recently presented at the Congress of the International Headache Society in September and will be published in future peer-reviewed publications. The most common adverse events reported in clinical trials include injection site induration, erythema, and pruritis.
