Green light for new medicines

by Gary Finnegan: The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of seven new medicines, including one advanced therapy medicinal product (ATMP), at its meeting on 29 March-1April.

This brings to 19 the total number of new medicines approved by the Committee in 2016. In addition, 12 medicines have been given extended licenses this year to date.

Medicines approved at the most recent meeting of the CHMP are:

• Strimvelis, a new gene therapy 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 anorphan designation and is an ATMP.

• Darzalex(daratumumab) received a conditional marketing authorisation for the treatment of relapsed and refractory multiple myeloma. Darzalex has an orphan designation and was reviewed under EMA’s accelerated assessment

• Galafold (migalastat) for the treatment of Fabry disease, a rare genetic disorder. Galafold has an orphan designation.

• Pandemic influenza vaccine H5N1 MedImmuneis the first pandemic live attenuated influenza vaccine against avian influenza (H5N1) to be recommended for approval in the European Union (EU). The vaccine is intended for pandemic preparedness.

• Flixabi(infliximab), a biosimilar monoclonal antibody, 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, for the prevention of nausea and vomiting associated with chemotherapy.