EMA approved 91 products in 2021

Written by | 12 Jan 2022 | Legislative and Regulatory

Thirteen new medicines were given the green light at the December meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). This brings to 91 the total number of products approved in a busy year for the agency.

The CHMP gave a positive opinion on the following products at its latest meeting:

  • Xevudy (sotrovimab), a monoclonal antibody for the treatment of COVID-19.
  • Oxbryta (voxelotor) for the treatment of haemolytic anaemia due to sickle cell disease.
  • Ngenla (somatrogon) to treat growth hormone deficiency in adolescents and children from 3 years of age.
  • Apexxnar(pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)) as prophylaxis against pneumococcal pneumonia and associated invasive disease.
  • Kerendia(finerenone) for treatment of chronic kidney disease associated with type 2 diabetes in adults.
  • Padcev(enfortumab vedotin) to treat adult patients with urothelial cancer.
  • Saphnelo(anifrolumab) for the treatment of moderate to severe systemic lupus erythematosus.
  • Tepmetko(tepotinib) for the treatment of patients with advanced non-small cell lung cancer.
  • Yselty(linzagolix choline) for the treatment of symptoms of uterine fibroids.
  • Okedi(risperidone), intended for the treatment of schizophrenia in adults.
  • Sitagliptin/Metformin hydrochloride Mylan(sitagliptin hydrochloride monohydrate / metformin hydrochloride) for the treatment of type 2 diabetes mellitus.
  • Sapropterin Dipharma(sapropterin) for the treatment of hyperphenylalaninemia.

In addition, extended indications were granted for Kineret (anakinra), an immunosuppressive medicine and Veklury (remdesivir), an antiviral medicine. Both can now be used to treat COVID-19 in certain circumstances. The Committee also published new advice on the use of the antiviral Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19.

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