The European Medicines Agency (EMA) recommended in March to allow 12 new drugs to be placed on the European Union market, according to data published by the agency on Friday, News.ro reported.

Medicines and supplements Photo: / Alamy / Alamy / Profimedia

The EMA is the body responsible for evaluating medicinal products for which pharmaceutical companies apply for marketing authorizations at a centralized level in the European Union.

Each month, EMA’s Committee for Medicinal Products for Human Use (CHMP) meets to decide whether to recommend authorization for medicinal products that have passed the evaluation process.

At the last meeting on March 18-21, CHMP experts recommended the approval of 12 medicinal products, of which 3 biosimilars and 3 generics, to be placed on the European Union market and the expansion of therapeutic indications for 6 more drugs.

The decision to authorize the sale rests with the European Commission, which usually follows the recommendations of EMA experts.

List of drugs recommended for registration

Therefore, during this month’s CHMP meeting, it was recommended that the following drugs be allowed:

  • Awiqli (icodec insulin) for the treatment of diabetes in adults.
  • Emblaveo (aztreonam-avibactam), a new antibiotic against multidrug-resistant infections.
  • Fabhalta (iptacopan), an oral agent for the treatment of adults with paroxysmal nocturnal hemoglobinuria.
  • Litenava (bevacizumab) for the treatment of patients with neovascular age-related macular degeneration.
  • Jubbonti (denosumab), a biosimilar, for the treatment of osteoporosis.
  • Omlyclo (omalizumab), a biosimilar, for the treatment of patients with asthma and chronic rhinosinusitis.
  • Wyost (denosumab), a biosimilar, for the prevention of bone manifestations in patients with advanced malignancies.
  • Agilus (dantrolene sodium, hemegeptahydrate), for the treatment of malignant hyperthermia.
  • Neoatrichone (dopamine hydrochloride) for the treatment of arterial hypotension in newborns, infants and children.
  • Dimethyl fumarate Accord, Dimethyl fumarate Mylan and Dimethyl fumarate Neuraxpharm (dimethyl fumarate), generics, for the treatment of patients with multiple sclerosis, relapsing-remitting form.

The CHMP recommended expanding the therapeutic indications for six medicines: Bimzelx, Nilemdo, Nustendi, Onivyde pegylated liposomal, Retsevmo and Xtandi.

Since the beginning of this year, the EMA has recommended the authorization of 25 medicines on the EU market and the expansion of therapeutic indications for 16 existing medicines.

In 2023, the EMA recommended the authorization of 77 medicines and expanded therapeutic indications for 77 existing treatments.