Advanced Therapies From Orchard & Kite Win EMA Thumbs Up

16 Oct 2020

Novartis’s siRNA for lowering cholesterol was also among the 10 new medicines that the European Medicines Agency this week said should be approved in the EU.

Gene editing genes therapy concept with nurse and DNA lab technician medical laboratory — A gene therapy for treating metachromatic leukodystrophy could soon be approved • Source: Shutterstock

The European Medicines Agency has recommended that 10 new treatments be awarded pan-EU marketing authorization, including Libmeldy (OTL-200), Orchard Therapeutics’ gene therapy for treating metachromatic leukodystrophy (MLD), and Leqvio (inclisiran), Novartis’s potential blockbuster cholesterol lowering drug.

If approved by the European Commission, Libmeldy will be the first commercial therapy and first gene therapy for eligible patients...