EMA recommends 10 medicines for approval in October meeting
Ten medicines have been recommended for marketing authorisation and 10 extensions of indication have been suggested by the EMA.
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended 10 medicines for approval at its October 2020 meeting.
The committee 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.
The CHMP also recommended granting a marketing authorisation for the gene therapy Libmeldy (autologous CD34+ cell enriched population that contains haematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene) to treat metachromatic leukodystrophy (MLD).
A marketing authorisation has also been suggested for Oxlumo (lumasiran), for the treatment of primary hyperoxaluria type 1. Approval has also been recommended for two antiretroviral medicines, Rekambys (rilpivirine) and Vocabria (cabotegravir), to be used together for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. According to the EMA, the two medicines are the first ARVs that come in a long-acting injectable formulation.
Fintepla (fenfluramine) received a positive opinion for the treatment of seizures associated with Dravet syndrome. Leqvio (inclisiran) has also been recommended for marketing authorisation by the EMA for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia.
Palforzia (defatted powder of Arachis hypogaea L., semen (peanuts)) received a positive opinion from the committee for desensitising children and adolescents to peanut allergy.
A positive opinion was adopted by CHMP for Trixeo Aerosphere (formoterol/glycopyrronium bromide/budesonide), for the maintenance treatment of chronic obstructive pulmonary disease in adults whose disease is not adequately controlled.
The committee additionally recommended granting a marketing authorisation for the generic medicine Lenalidomide Mylan (lenalidomide) for the treatment of multiple myeloma and follicular lymphoma.
Extensions of indication were recommened by the CHMP for Blincyto, Dupixent, Edistride, Forxiga, Humira, Lacosamide UCB, Opdivo, Recarbrio, Tremfya and Vimpat.
The EMA’s CHMP also recommended the addition of a new route of administration (intramuscular use) for Plegridy.
Blincyto, Dupixent, Edistride, Fintepla (fenfluramine), Forxiga, HUMIRA®, Lacosamide UCB, Lenalidomide Mylan (lenalidomide), Leqvio (inclisiran), Libmeldy, Opdivo, Oxlumo (lumasiran), Palforzia, Plegridy, Recarbrio, Rekambys (rilpivirine), Tecartus, Tremfya, Trixeo Aerosphere (formoterol/glycopyrronium bromide/budesonide), Vimpat, Vocabria (cabotegravir)