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Johnson & Johnson: CHMP marketing authorisation

(CercleFinance.com) - Johnson & Johnson's Janssen Pharmaceutical today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a conditional marketing authorisation (CMA) for TECVAYLI® (teclistamab) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).


"CMA is the approval of a medicine that addresses unmet medical needs of patients based on less comprehensive data than normally required, where the benefit of immediate availability of the medicine outweighs the risk, and the applicant is able to provide comprehensive clinical data in the future," the group said.

The EMA conducted an accelerated assessment of teclistamab in December 2021. Accelerated assessment shortens the time taken for the CHMP to review a marketing authorisation (MA) application and is granted when a medicinal product is of major interest for public health and therapeutic innovation.


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