EMA's CHMP recommends four new meds for approval at its December meeting
The European Medicines Agency’s human medicines committee (CHMP) recommended four novel medicines for approval at its December 2022 meeting. A final approval decision from the European Commission can be expected within the next two or three months.
The CHMP recommended granting a conditional marketing authorization for the advanced therapy medicinal product (ATMP) Hemgenix (etranacogene dezaparvovec), the first gene therapy for the treatment of severe and moderately severe hemophilia B.
The approval was granted to CSL Behring, a subsidiary of Australia CSL Limited (ASX: CSL), which developed the drug in partnership with Dutch firm uniQure (Nasdaq: QURE) and gained its first approval in the USA last month.
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