Sanofi: complete response letter from FDA for Zynquista
(CercleFinance.com) - Sanofi has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug application for the investigational drug Zynquista (sotagliflozin).
In this statement, the FDA informs the pharmaceutical giant and its partner Lexicon that the drug cannot be approved as it is. As a result, both groups will work closely together with the FDA to define the next appropriate steps.
The French laboratory recalls that this dual inhibitor of sodium-glucose cotransporter type-1 and 2 (SGLT1 and SGLT2) is intended for the treatment of type-1 diabetes in adults, in combination with insulin.
Copyright (c) 2019 CercleFinance.com. All rights reserved.
In this statement, the FDA informs the pharmaceutical giant and its partner Lexicon that the drug cannot be approved as it is. As a result, both groups will work closely together with the FDA to define the next appropriate steps.
The French laboratory recalls that this dual inhibitor of sodium-glucose cotransporter type-1 and 2 (SGLT1 and SGLT2) is intended for the treatment of type-1 diabetes in adults, in combination with insulin.
Copyright (c) 2019 CercleFinance.com. All rights reserved.