The new medicines accepted include one advanced therapy medicinal product (ATMP), a medicine reviewed under the EMA’s accelerated assessment scheme and a pandemic flu vaccine.
- Strimvelis, a new gene therapy designed to treat 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
- Darzalex (daratumumab) for the treatment of relapsed and refractory multiple myeloma. Daratumumab has an orphan designation and was reviewed under EMA’s accelerated assessment scheme
- Galafold (migalastat) for the treatment of Fabry disease, a rare genetic disorder. Migalastat also has an orphan designation
- Pandemic influenza vaccine H5N1 MedImmune also received a positive opinion from the CHMP. This is the first pandemic live attenuated influenza vaccine against avian influenza (H5N1) to be recommended for approval in the European Union. The vaccine is intended for pandemic preparedness
- Flixabi (infliximab), a biosimilar monoclonal antibody, was granted a positive opinion for the treatment of rheumatoid arthritis, adult and paediatric Crohn's disease, ulcerative colitis, paediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis
- Neparvis (sacubitril/valsartan) for the treatment of chronic heart failure with reduced ejection fraction
- Palonosetron Accord (palonosetron), a generic medicine, also received a positive opinion for the prevention of nausea and vomiting associated with chemotherapy.
For more information on these accepted treatments visit: http://bit.ly/chmp0316