Orchard Therapeutics Secures Swedish Reimbursement Agreement for Libmeldy
Global gene therapy company, Orchard Therapeutics (Nasdaq: ORTX) has reached an agreement that will allow reimbursed access to Libmeldy for eligible metachromatic leukodystrophy (MLD) patients in Sweden.
MLD is a rare and life-threatening inherited disease that causes damage to the nervous system. Infants diagnosed with MLD have a life expectancy of five years and adults typically live six to 14 years following the onset of symptoms.
- The Swedish New Therapies (NT) Council gave Libmeldy the strongest possible recommendation for use following a health economic evaluation by FINOSE, a health technology assessment consortium between Finland, Norway and Sweden.
- The company has previously secured similar agreements with reimbursement authorities in the United Kingdom, Italy and Germany. These are a key component of the company’s commercial expansion plans in Europe.
- Orchard is in the final stages of qualifying a sixth treatment center in Europe at the University Hospital Skåne Lund in Sweden. The center will serve as the primary site for eligible patients referred from the country and the Nordic region.
- Libmeldy is approved in the European Union, UK, Iceland, Liechtenstein and Norway. OTL-200 is an investigational therapy in the United States.
Orchard says Libmeldy has the potential to transform the lives of eligible children with a single administration. The drug was approved by the European Commission for the treatment of early-onset MLD based on data encompassing more than 10 years of follow-up.