The European Medicines Agency recommends 10 medicines for approval in October meeting

pharmafile | October 22, 2020 | News story | Research and Development  

The EMA has recommended marketing authorisation for ten medicines and has also suggested ten label extensions. 

The agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting a conditional marketing authorisation for Tecartus (autologous anti-CD19-transduced CD3+ cells) for the treatment of adult patients with a rare cancer of white blood cells called mantle cell lymphoma. 

It also recommends authorisation for Libmeldy, a gene therapy to treat metachromatic leukodystrophy. Another was suggested for Oxlumo, a treatment for primary hyperoxaluria type 1, as well as two antiretroviral medicines, Rekambys and Vocabria, which are used together to treat HIV. The EMA says these are the first types of antiretroviral drugs to be made available in the region that come in a long-acting injectable formulation.

CHMP also gave a positive opinion to Fintepla for the treatment of seizures associated with Dravet syndrome, Leqvio for the treatment of primary hypercholesterolaemia, Palforzia for desensitising children to peanut allergies, Trixeo Aerosphere for the maintenance treatment of chronic obstructive pulmonary disease and Mylan’s generic version of lenalidomide for the treatment of multiple myeloma and follicular lymphoma.

CHMP also recommended the label extensions for Blincyto, Dupixent, Edistride, Forxiga, Humira, Lacosamide UCB, Opdivo, Recarbrio, Tremfya and Vimpat.

Conor Kavanagh

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