Sanofi: FDA grants cemiplimab priority review
(CercleFinance.com) - Sanofi has announced that the FDA has granted priority consideration for the application for a biologic product license for cemiplimab, a drug for the treatment of metastatic or locally advanced squamous cell carcinoma in patients who are not suitable for surgery.
The US FDA granted the designation of "discovery capital" in September 2017 and is expected to make its decision on 28 October 2018. The application for a biologic license is based on the results of a Phase II pivotal clinical trial.
Cemiplimab is being jointly developed by Sanofi and Regeneron as part of a global collaboration agreement. It is in clinical development and no regulatory body has yet fully evaluated his safety and efficacy profiles.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
The US FDA granted the designation of "discovery capital" in September 2017 and is expected to make its decision on 28 October 2018. The application for a biologic license is based on the results of a Phase II pivotal clinical trial.
Cemiplimab is being jointly developed by Sanofi and Regeneron as part of a global collaboration agreement. It is in clinical development and no regulatory body has yet fully evaluated his safety and efficacy profiles.
Copyright (c) 2018 CercleFinance.com. All rights reserved.