Slew of recommendation for drug approvals from EMA/CHMP

At its October meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 10 medicines for approval. These now go the European Commission, which usually provides a final decision within two to three months.

The Committee recommended granting a conditional marketing authorization for Gilead Sciences (Nasdaq: GILD) subsidiary Kite Pharma’s 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. Since Tecartus addresses an unmet medical need, it benefited from support within the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines. The drug was approved in the USA in July this year.

The CHMP recommended granting a marketing authorization for Orchard Therapeutics’ (Nasdaq: ORTX) gene therapy Libmeldy (autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene) to treat metachromatic leukodystrophy (MLD). MLD is a rare inherited metabolic disease that affects the nervous system and causes the progressive loss of motor function and cognitive ability and, ultimately, death. There is currently no cure for MLD.