EMA recommends 15 medicines for approval following December meeting

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has 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. The CHMP also 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 and of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia.

The CHMP recommended a marketing authorisation under exceptional circumstances for Lumoxiti (moxetumomab pasudotox) for the treatment of relapsed or refractory hairy cell leukaemia.

The committee suggested 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 also recommended granting a marketing authorisation for Sibnayal (potassium citrate/potassium hydrogen carbonate) for the treatment of distal renal tubular acidosis.

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 EMA further 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. 

The committee recommended nine extensions of indication for Bavencio, Doptelet, Iscover, Keytruda, Nplate, Nordimet, Plavix, Rinvoq and Spravato.

The CHMP adopted a positive opinion recommending a change to the product information for Veklury (remdesivir) to provide clearer instructions in which COVID-19 patients requiring supplementary oxygen it should be used.