FDAnews Drug Daily Bulletin

EMA’s CHMP Issues Positive Recommendations for 6 New Drugs

April 8, 2016

European regulators are backing six new drugs in the EU to treat conditions ranging from cancer to rare genetic disorders.

The European Medicines Agency’s Committee for Medicinal Products for Human Use made the following positive recommendations last week to the European Commission:

  • Marketing authorization for GlaxoSmithKline Trading Service’s gene therapy drug Strimvelis, an orphan therapy for patients with adenosine-deaminase-deficient severe combined immunodeficiency;
  • Marketing authorization for Amicus Therapeutics UK’s orphan therapy migalastat for the treatment of Fabry disease;
  • Conditional marketing authorization for Janssen-Cilag International’s orphan drug Darzalex, which treats relapsed and refractory multiple myeloma;
  • Positive opinion for MedImmune’s vaccine for H5N1 avian flu to guard against a pandemic;
  • Positive opinion for Samsung Bioepsis UK’s biosimilar Flixabi, which treats a host of conditions, including rheumatoid arthritis and psoriasis;
  • Positive opinion for Accord Healthcare’s drug Palonosetron Accord, which is used to treat chemotherapy-induced nausea.