Bumper December meeting sees CHMP recommend 15 new medicines

The European Medicines Agency’s (EMA) committee for Medicinal Products for Human Use (CHMP) recommended 15 new medicines for approval in its final meeting of the year.

First to score a recommendation was AstraZeneca/Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for the treatment of metastatic HER2-positive breast cancer, following an accelerated review of the anti-HER2 therapy.

The CHMP also recommended Dynavax’s Heplisav (hepatitis B surface antigen) for active immunisation against hepatitis B virus infection and ViiV Healthcare’s Rukobia (fostemsavir) for the treatment of multidrug resistant HIV-1 infection.

Up next, the CHMP adopted a positive opinion for Bristol Myers Squibb’s Inrebic (fedratinib) for the treatment of primary myelofibrosis and myelofibrosis secondary to polycythaemia vera, as well as essential thrombocythaemia.

The committee then recommended granting a marketing authorisation ‘under exceptional circumstances’ for AstraZeneca’s Lumoxiti (moxetumomab pasudotox) to treat relapsed/refractory hairy cell leukaemia – a cancer which affects white blood cells known as B-lymphocytes.

In addition, Eli Lilly’s Retsevmo (moxetumomab pasudotox) scored a positive recommendation for the treatment of RET gene fusion-positive cancers and Seagen’s Tukysa (tucatinib) scored a nod for the treatment of HER2-positive locally advanced or advanced metastatic breast cancer.

Rare disease med Sibnayal (potassium citrate/potassium hydrogen carbonate) was handed a positive recommendation for the treatment of the rare genetic disorder distal renal tubular acidosis, which affects the kidneys.

The CHMP also recommended biosimilar medicines Mylan's Kixelle (insulin aspart), for the treatment of diabetes mellitus and Celltrion Healthcare's Yuflyma (adalimumab), for the treatment of certain inflammatory and autoimmune disorders.

The committee adopted a positive opinion for Xeris Pharmaceuticals' Ogluo (glucagon), a hybrid medicine for the treatment of severe hypoglycaemia in diabetes mellitus.

Rounding out the new recommendations were a number of generic medications, including Lenalidomide Krka, Lenalidomide Krka d.d., Lenalidomide Krka d.d. Novo mesto and Sunitinib Accord (sunitinib), for the treatment of cancer.

A total of nine therapeutics also scored label extensions, including Bavencio, Doptelet, Iscover, Keytruda, Nplate, Nordimet, Plavix, Rinvoq and Spravato.

The CHMP also recommended changing the product information for Gilead’s antiviral COVID-19 drug Veklury (remdesivir), to provide clearer instructions in which patients requiring supplementary oxygen due to COVID-19 it should be used.