Following a positive opinion from the European Medicines Agency (EMA), the transfer of marketing authorization of Strimvelis from Orchard Therapeutics has been approved by the European Commission. Fondazione Telethon (Italy) will now be responsible for providing the gene therapy to eligible patients in the European Union.
Fondazione Telethon, one of the main Italian biomedical charities, and Orchard Therapeutics, a global gene therapy leader, today announced the completion of the transfer of the marketing authorization for Strimvelis, a gene therapy approved by the EMA in 2016 for the treatment of adenosine deaminase severe combined immunodeficiency (ADA-SCID).
The marketing authorization transfer was approved on July 17th by the European Commission following a positive opinion from EMA. The European manufacturing and distribution rights have been fully transferred to Fondazione Telethon from its former holder, Orchard Therapeutics, which previously announced it would discontinue investment in and seek strategic alternatives for its programs in rare primary immune deficiencies, including Strimvelis.
Read the full Press Release: here.