Ipsen: COMP confirms negative opinion for Bylvay
(CercleFinance.com) - Ipsen announces that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency has confirmed its negative opinion, recommending that the orphan designation of Bylvay (odévixibat) in Alagille syndrome (AGS) not be maintained.
However, the pharmaceutical company says that last July it received a positive opinion from the CHMP recommending approval of this product on the basis of data from the ASSERT phase III clinical trial in GAS.
Ipsen now plans to resubmit to the EMEA a new marketing authorisation application under a new brand name for the treatment of GAS by the end of 2023.
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However, the pharmaceutical company says that last July it received a positive opinion from the CHMP recommending approval of this product on the basis of data from the ASSERT phase III clinical trial in GAS.
Ipsen now plans to resubmit to the EMEA a new marketing authorisation application under a new brand name for the treatment of GAS by the end of 2023.
Copyright (c) 2023 CercleFinance.com. All rights reserved.