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European Medicines Agency 

New antibiotic and migraine drug among 13 medicines recommended by EMA

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended 13 medicines for approval, including three orphan medicines.

Of these, one recommendation was for the monoclonal antibody galcanezumab (Emgality; Eli Lilly Nederland B.V.) for the treatment of migraine. Galcanzumab works by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule thought to be involved in migraine attacks.

At its meeting, held on 17–20 September 2018, the CHMP also recommended granting a marketing authorisation for meropenem trihydrate/vaborbactam (Vabomere; Rempex London Ltd), a new antibiotic, for the treatment of various severe infections in adults, including complicated urinary tract infections and hospital-acquired pneumonia. The EMA highlighted that the development of new and effective antibiotics is one of the most powerful tools in the fight against antimicrobial resistance.

A depot formulation of buprenorphine (Buvidal; Camurus AB) for the treatment of opioid dependence was also recommended for approval as a hybrid medicine. Other products that were granted a positive opinion by the CHMP included doravirine/lamivudine/tenofovir/disoproxil (Delstrigo; Merck Sharp & Dohme B.V.) and doravirine (Pifeltro; Merck Sharp & Dohme B.V.) for the treatment of HIV-1 infection.

Also discussed at the meeting was the CHMP’s ongoing review of impurities in valsartan. Following the detection of very low levels of N-nitrosodiethylamine (NDEA) in another active substance, losartan, the CHMP has expanded its review to encompass four other ‘sartans’ – candesartan, irbesartan, losartan and olmesartan. 

The agenda of the September 2018 meeting is published on the EMA’s website.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205493

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