Fifteen new medicines recommended for approval.
EMA’s human medicines committee (CHMP) recommended 15 medicines for approval at its December 2020 meeting.
The Committee recommended granting a conditional marketing authorisation for Enhertu (trastuzumab deruxtecan) for the treatment of metastatic HER2-positive breast cancer. Enhertu was reviewed under EMA’s accelerated assessment programme.
The CHMP adopted a positive opinion for Heplisav B (hepatitis B surface antigen) for the active immunisation against hepatitis B virus infection.
Inrebic* (fedratinib) received a positive opinion 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).
The Committee recommended granting a marketing authorisation under exceptional circumstances for 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.
The Committee recommended granting a conditional marketing authorisation for 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) received a positive opinion for the treatment of multidrug resistant HIV-1 infection.
The CHMP recommended granting a marketing authorisation for 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) received a positive opinion for the treatment of HER2-positive locally advanced or metastatic breast cancer.
The CHMP recommended granting marketing authorisations for two biosimilar medicines: Kixelle (insulin aspart), for the treatment of diabetes mellitus; and Yuflyma (adalimumab), for the treatment of certain inflammatory and autoimmune disorders.
The CHMP recommended granting marketing authorisations for four generic medicines: 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.
The CHMP recommended granting a marketing authorisation for Ogluo (glucagon), a hybrid medicine for the treatment of severe hypoglycaemia in diabetes mellitus. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.
Nine recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Bavencio, Doptelet, Iscover, Keytruda, Nplate, Nordimet, Plavix, Rinvoq and Spravato.
Restriction of indication for Veklury
The CHMP adopted a positive opinion recommending a change to the product information for Veklury (remdesivir) to provide clearer instructions in which patients requiring supplementary oxygen because of COVID-19 it should be used.
Withdrawal of application
The application for an initial marketing authorisation for Artobend (autologous human chondrocytes in vitro expanded) was withdrawn. This advanced therapy medicinal product (ATMP) was intended for the treatment of cartilage defects of the knee joint.
* This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA’s Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.
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