Merck: thumbs up for Prevymis from the CHMP
(CercleFinance.com) - Merck announced on Tuesday that it had received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) with a view to obtaining marketing authorisation in Europe for its Prevymis product in kidney transplant patients.
The positive opinion concerns the prevention of cytomegalovirus (CMV) disease in CMV-positive adult kidney transplant recipients.
Merck says that the CHMP also issued a positive opinion on an extension (from 100 to 200 days) of the drug's use in the prevention of disease in adults who have received an allogeneic hematopoietic stem cell transplant.
The European Commission's final decision on these two indications is expected within 12 months from now.
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The positive opinion concerns the prevention of cytomegalovirus (CMV) disease in CMV-positive adult kidney transplant recipients.
Merck says that the CHMP also issued a positive opinion on an extension (from 100 to 200 days) of the drug's use in the prevention of disease in adults who have received an allogeneic hematopoietic stem cell transplant.
The European Commission's final decision on these two indications is expected within 12 months from now.
Copyright (c) 2023 CercleFinance.com. All rights reserved.