After Kyowa Kirin buyout, Orchard scores FDA approval for first MLD gene therapy in the US

Kyowa Kirin’s bet on Orchard Therapeutics has paid off, furnishing the Japanese drugmaker with a newly approved gene therapy in the U.S. that’s already started to prove itself in Europe over the past several years.

The FDA on Monday gave a thumbs-up to Orchard’s Lenmeldy, also known as atidarsagene autotemcel, as the first U.S.-approved gene therapy for kids with certain types of metachromatic leukodystrophy (MLD).