CHMP News – March 2016
Seven new medicines recommended for approval
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 authorisation for 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 an orphan designation and is an ATMP (advanced-therapy medicinal product).
The Committee recommended granting a conditional marketing authorisation for Darzalex (daratumumab) for the treatment of relapsed and refractory multiple myeloma. Darzalex has an orphan designation and was reviewed under EMA’s accelerated assessment scheme.
The Committee recommended granting a marketing authorisation for Galafold (migalastat) for the treatment of Fabry disease, a rare genetic disorder. Galafold has anorphan 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 (EU). The vaccine is intended for pandemic preparedness.
A biosimilarmonoclonal antibody, Flixabi (infliximab), was granted a positive opinion by the Committee for the treatment of rheumatoid arthritis, adult and paediatric Crohn's disease, ulcerative colitis, paediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
The CHMP also granted a positive opinion for Neparvis (sacubitril/valsartan) for the treatment of chronic heart failure with reduced ejection fraction.
A generic medicine, Palonosetron Accord (palonosetron), received a positive opinion from the Committee for the prevention of nausea and vomiting associated with chemotherapy.
Three recommendations on extensions of therapeutic indications
The Committee recommended extensions of indications for Halaven, Humira and Opdivo.
Re-examination procedure concluded
The CHMP concluded a re-examination procedure, issuing a final negative opinion for Heparesc Dropcys (mercaptamine). A questions-and-answers document on this opinion is available on EMA's website.
Review on vancomycin
The CHMP started a review of medicines containing the antibiotic vancomycin as part of its efforts to update product information of older antibacterial agents in the context of the fight against antimicrobial resistance. The revision of product information for critically important antibiotics is considered an important way of promoting appropriate use to ensure they remain available to EU patients. For more information, please see HALMED's website.
Review on Symbioflor 2
The Committee started a review of the medicine Symbioflor 2 (Escherichia coli bacteria), which is authorised in some Member States of the EU for treating diseases affecting the stomach and gut including irritable bowel syndrome.
This medicine has not been authorised in the Republic of Croatia.
For more information, please see EMA's website.
Review of medicines for which studies have been conducted at Alkem BE, India
The CHMP also started a review of medicines for which studies have been conducted at the Alkem BE site in Mumbai, India. This follows a good clinical practice (GCP) inspection of this site which raised concerns regarding study data used to support the marketing authorisation applications of some medicines in the EU. For more information, please see the start of referral documents in the grid below.
For more information, please see HALMED's website.
More information on the CHMP's January 2016 meeting can be found here.