EMA/CHMP recommendations for seven new medicines

2 April 2016
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines, including one advanced therapy medicinal product (ATMP), for approval at its March meeting.

The CHMP recommended granting a marketing authorization for Strimvelis, a new gene therapy from UK pharma major GlaxoSmithKline (LSE: GSK) intended for the treatment of patients with adenosine-deaminase-deficient severe combined immunodeficiency (ADA-SCID), who have no matching donor for a stem cell transplant. Strimvelis has an orphan designation and is an ATMP.

If approved, Strimvelis will become the first corrective ex-vivo gene therapy for children to achieve regulatory approval anywhere in the world.

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