Of the ten advanced therapy medicinal products to have been approved in Europe, three – Strimvelis, Zalmoxis and Holoclar – have been developed in Italy, which is rapidly asserting itself as a leading player in the field of cell and gene therapies.

Strimvelis was developed at the San Raffaele Telethon Institute for Gene Therapy (SR-Tiget), Milan, and received marketing authorisation for the treatment of ADA-SCID, a severe and very rare form of immunodeficiency, in May 2016. The first ex vivo gene therapy to be approved in the world, it was brought to market under a strategic alliance with pharmaceutical giant GlaxoSmithKline. In April 2018, GlaxoSmithKline signed a strategic agreement to transfer its rare disease gene therapy portfolio (including Strimvelis) to Orchard Therapeutics.