Ten new medicines backed for EU approval

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended ten new medicines for approval at its October 2020 meeting.

The CHMP backed conditional marketing authorisation for Kite’s – a Gilead company – CAR-T therapy Tecartus for the treatment of adult patients with mantle cell lymphoma.

Tecartus benefitted from the EMA’s PRIME scheme, which is the agency’s platform for early and enhanced dialogue with developers of promising new medicines.

The CHMP also handed Orchard Therapeutics a positive opinion for its gene therapy Libmeldy for the treatment of early-onset metachromatic leukodystrophy (MLD).

MLD is a rare genetic disease that affects the nervous system and causes the progressive loss of motor function and cognitive ability.

Another medication for a rare disease – Alnylam’s Oxlumo (lumasiran) – was backed for use in primary hyperoxaluria 1. Like Tecartus, Oxlumo was accepted in the EMA’s PRIME scheme and benefitted from extra support offered by the agency, including a accelerated assessment.

The EMA has also recommended granting marketing authorisations for two new antiretroviral medicines –Janssen's Rekambys (rilpivirine) and ViiV Healthcare’s Vocabria (cabotegravir) – to be used together for the treatment of HIV. This makes the two medicines the first antiretrovirals to come in a long-acting injectable form.

Also backed for approval were Zogenix’s Fintepla (fenfluramine) for the treatment of seizures associated with Dravet syndrome and Novarits’ heart med Leqvio (inclisiran) for hypercholesterolaemia or mixed dyslipidaemia.

Aimmune Therapeutic’s Palforzia received a positive opinion from the committee for use in desensitising children and adolescents to peanut allergy.

Rounding out the positive opinions were Trixeo Aerosphere for the maintenance treatment of chronic obstructive pulmonary disease in adults whose disease is not adequately controlled, and Mylan’s generic Lenalidomide for the treatment of multiple myeloma and follicular lymphoma.

The meeting also resulted in ten recommendations for extensions of therapeutic indication, including Amgen’s immunotherapy Blincyto (blinatumomab), Sanofi’s eczema drug Dupixent (dupilumab), AstraZeneca’s diabetes drug Forxiga (dapagliflozin), AbbVie’s blockbuster autoimmune drug Humira (adalimumab), UCB’s generic epilepsy med Lacosamide, BMS’ checkpoint inhibitor Opdivo (nivolumab), Merck’s Gram-negative antibiotic Recarbrio, Janssen’s psoriasis drug Tremfya (guselkumab) and UCB’s Vimpat.