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Merck Gets Positive CHMP Opinion For Tablet Formulation Of Noxafil - Quick Facts

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News
rttnewslogo20mar2024

Merck (MRK), known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has adopted a positive opinion recommending approval of a new, investigational tablet formulation of Noxafil or posaconazole.

The CHMP positive opinion will be reviewed by the European Commission, which if approved, grants a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members Iceland, Liechtenstein and Norway.

In the U.S., Noxafil delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia (low white blood cell counts) from chemotherapy.

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