FDA to respond to Teva migraine drug application in Sep

Teva Photo: ASAP Creative Shutterstock

Migraine treatment fremanezumab is one of the main branded drugs on which Teva is banking on in the coming years.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) today confirmed that the US Food and Drug Administration (FDA) has extended the goal date of the Biologics License Application (BLA) for migraine treatment fremanezumab. The Prescription Drug User Fee Act (PDUFA) action date for fremanezumab is set for September 16, 2018. There are no additional data requests from the FDA.

Migraine treatment fremanezumab is one of the main branded drugs on which Teva is banking on in the coming years. There is no guarantee that the FDA's response in September will be positive, it could be negative or more information could be requested. The delay was caused by problems discovered in one of the drug's production plant. If approval is given in September, the drug could be on the market before the end of the year.

Teva EVP global R&D Hafrun Fridriksdottir said, “Our primary goal is to bring preventive treatment options to migraine patients as quickly as possible. We are encouraged by the ongoing communications with the FDA as we work to bring this important therapy to patients.”

Teva EVP head of North America Commercial Brendan O'Grady said, “We are incredibly excited to move this product forward in the review process and we are preparing to launch the product immediately when approved. Migraine patients have waited years for new preventive treatments to enter the market.”

Published by Globes [online], Israel business news - www.globes-online.com - on May 23, 2018

© Copyright of Globes Publisher Itonut (1983) Ltd. 2018

5 Comments
View comments in rows
Update by email about comments talkback
POST
Comments
Teva Photo: ASAP Creative Shutterstock
Teva Photo: ASAP Creative Shutterstock
Twitter Facebook Linkedin RSS Newsletters גלובס Israel Business Conference 2018