Orchard Therapeutics Announces Reimbursement Agreement for Libmeldy

Orchard Therapeutics, a global gene therapy company, announced on April 11, 2022 that it has reached a reimbursement agreement with the Italian Medicines Agency to enable access to Libmeldy (atidarsagene autotemcel) for all children with metachromatic leukodystrophy (MLD) who fall within the scope of the European marketing authorization.

MLD is a rare and life-threatening inherited disease of the body’s metabolic system that occurs in approximately one in every 100,000 live births. It is caused by a mutation in the arylsulfatase-A (ARSA) gene that results in the accumulation of sulfatides in the brain, liver, gallbladder, kidneys, and/or spleen. Patients with MLD gradually lose the ability to move, talk, swallow, ear, and see.

“Following the February announcement of our landmark reimbursement agreement with NHS England, we are pleased that the Italian Medicines Agency has recognized the significant potential clinical benefit Libmeldy offers, granting it innovative status and agreeing to reimburse the therapy for all eligible MLD patients in the country,” said Braden Parker, chief commercial officer of Orchard Therapeutics, in a press release. “The momentum on our reimbursement negotiations is encouraging, as is our early progress in identifying patients in both Europe and the Middle East who may benefit from this therapy.”