EU watchdog approves 10 new drugs

Article written by Gary Finnegan.

The European Medicines Agency (EMA) has given the green light for ten new medicines at the latest meeting of its influential Committee for Medicinal Products for Human Use (CHMP). This brings to 76 the total number of products approved by the Committee in 2020.

At its October meeting, the CHMP approved the following:

• Tecartus for the treatment of adult patients with a rare cancer of white blood cells called mantle cell lymphoma.
• Libmeldy a gene therapy used to treat metachromatic leukodystrophy (MLD).  
• Oxlumo (lumasiran) for the treatment of primary hyperoxaluria type 1, a rare inherited disorder.  
• Rekambys (rilpivirine) and Vocabria (cabotegravir), to be used together for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
• Fintepla (fenfluramine) for the treatment of seizures associated with Dravet syndrome.
• Leqvio (inclisiran), for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia.
• Palforzia for desensitising children and adolescents to peanut allergy.
• Trixeo Aerosphere (formoterol / glycopyrronium bromide / budesonide), for the maintenance treatment of chronic obstructive pulmonary disease in adults whose disease is not adequately controlled.
• Lenalidomide Mylan (lenalidomide), for the treatment of multiple myeloma and follicular lymphoma.

The Committee also recommended extensions of indication for Blincyto Dupixent, Edistride, Forxiga, Humira, Lacosamide UCB, Opdivo, Recarbrio, Tremfya and Vimpat.