European Medicines Agency approves five new medicines


  • Dawn O'Shea
  • Univadis Medical News
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The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has approved five new medicines.

At its December meeting, the CHMP approved Beovu (brolucizumab) for the treatment of neovascular (wet) age-related macular degeneration.

Brolucizumab is an anti-neovascularisation agent which inhibits vascular endothelial growth factor A, thereby suppressing endothelial cell proliferation, reducing pathological neovascularisation and decreasing vascular permeability.

Beovu will be available as a 120 mg/mL solution for injection.

The CHMP also recommended granting marketing authorisation for Recarbrio (imipenem/cilastatin/ relebactam) for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.

The fixed-dose combination will be available as a 500 mg/500 mg/250 mg powder for solution for infusion. The indication states “consideration should be given to official guidance on the appropriate use of antibacterial agents."

The biosimilar medicine Amsparity (adalimumab) received approval for indications related to:

  • Rheumatoid arthritis
  • Polyarticular juvenile idiopathic arthritis
  • Enthesitis‑related arthritis
  • Ankylosing spondylitis
  • Psoriatic arthritis
  • Psoriasis
  • Hidradenitis suppurativa
  • Crohn’s disease
  • Ulcerative colitis
  • Uveitis

Two generic medicines received positive opinions:

  • Azacitidine Accord (azacitidine) for myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia.
  • Dexmedetomidine Accord (dexmedetomidine) for induction of light-moderate sedation of adults in an intensive care unit.