EU approved 96 new medicines in 2020

Written by | 14 Jan 2021 | Legislative and Regulatory

The European Medicines Agency gave its backing to 15 new medicines at its December meeting, taking its total for the year to 96.

This rounded off a busy year for the Amsterdam-based regulator which adapted to its new headquarters after a lengthy relocation from London, while also responding to global pandemic by working closely with companies developing new COVID-19 vaccines and medicines.

The Agency’s human medicines committee (CHMP) gave the green light for the following products in December:

  • Enhertu (trastuzumab deruxtecan) for the treatment of metastatic HER2-positive breast cancer.
  • Heplisav B (hepatitis B surface antigen) for the active immunisation against hepatitis B virus infection.
  • Inrebic* (fedratinib) for the treatment of primary myelofibrosis (an uncommon type of bone marrow cancer) and of myelofibrosis secondary to polycythaemia vera (a type of blood cancer) or essential thrombocythaemia (a rare chronic blood cancer).
  • Lumoxiti* (moxetumomab pasudotox) for the treatment of relapsed or refractory hairy cell leukaemia, a cancer of a type of white blood cell called B-lymphocytes.
  • Retsevmo (selpercatinib) for the treatment of cancers that display a rearranged during transfection (RET) gene fusion: RET-fusion positive non-small cell lung cancer, RET-fusion positive thyroid cancer and RET-mutant medullary-thyroid cancer.
  • Rukobia (fostemsavir) for the treatment of multidrug resistant HIV-1 infection.
  • Sibnayal* (potassium citrate / potassium hydrogen carbonate) for the treatment of distal renal tubular acidosis, a rare genetic disorder that affects the ability of the kidneys to remove acid from the blood.
  • Tukysa (tucatinib) for the treatment of HER2-positive locally advanced or metastatic breast cancer.
  • Kixelle (insulin aspart), for the treatment of diabetes mellitus; and Yuflyma (adalimumab), for the treatment of certain inflammatory and autoimmune disorders.
  • Lenalidomide Krka (lenalidomide), for the treatment of multiple myeloma and follicular lymphoma; Lenalidomide Krka d.d. (lenalidomide), for the treatment of multiple myeloma, myelodysplastic syndromes, and follicular lymphoma; Lenalidomide Krka d.d. Novo mesto (lenalidomide), for the treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma; and Sunitinib Accord (sunitinib), for the treatment of cancer.
  • Ogluo (glucagon), a hybrid medicine for the treatment of severe hypoglycaemia in diabetes mellitus.

Nine recommendations on extensions of therapeutic indication were agreed for Bavencio, Doptelet, Iscover, Keytruda, Nplate, Nordimet, Plavix, Rinvoq and Spravato

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