CHMP closes out 2020 by recommending 15 medicines

Regulatory NewsRegulatory News | 14 December 2020 |  By 

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended 15 medicines for authorization following its December meeting.
Among the medicines are eight new drugs and biologics, four generics, two biosimilars and one hybrid medicine. The new drugs included three products with orphan designation: AstraZeneca’s Lumoxiti (moxetumomab pasudotox), which was recommended under exceptional circumstances to treat relapsed or refractory hairy cell leukemia; Celgene’s myelofibrosis drug Inrebic (fedratinib); and Advicenne’s distal renal tubular acidosis treatment Sibnayal (potassium citrate/potassium hydrogen carbonate).
Following an accelerated assessment, the committee recommended conditional marketing authorization for Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) for the treatment of metastatic HER2-positive breast cancer. The committee also recommended conditionally authorizing Eli Lilly’s Retsevmo (selpercatinib) to treat certain RET-fusion positive cancers.
The other new drugs recommended for authorization include Dynavax’s Heplisav B (hepatitis B surface antigen) vaccine for active immunization against hepatitis B, ViiV’s multidrug resistant HIV-1 treatment Rukobia (fostemsavir) and Seagen’s Tukysa (tucatinib) to treat HER2-positive locally advanced or metastatic breast cancer.
The two biosimilars recommended are Mylan’s insulin aspart product Kixelle and Celltrion’s Humira biosimilar Yuflyma (adalimumab). Of the four generics recommended, three of the recommendations went to KRKA, d.d., Novo mesto for its generic versions of Revlimid (lenalidomide), and one went to Accord Healthcare’s generic version of Sutent (sunitinib). The lone hybrid medicine recommended this month was Xeris Pharmaceuticals’ Ogluo (glucagon) to treat severe hypoglycemia in patients with diabetes mellitus.
In addition to the new medicines recommended, CHMP recommended extending the therapeutic indication of nine medicines, Merck KGaA’s Bavencio (avelumab), Swedish Orphan Biovitrum’s Doptelet (avatrombopag), Sanofi-Aventis’ Iscover (clopidogrel) and Plavix (clopidogrel), Merck Sharp & Dohme’s Keytruda (pembrolizumab), Amgen’s Nplate (romiplostim), Nordic Group’s Nordimet (methotrexate), AbbVie’s Rinvoq (upadacitinib) and Janssen-Cilag’s Spravato (esketamine).
The committee also recommended changing the indication of Gilead’s COVID-19 treatment Veklury (remdesivir) to clarify what patients the drug should be used to treat. Initially, the indication was to treat COVID-19 in patients ages 12 and older who weigh at least 40kg with pneumonia requiring supplemental oxygen. The indication has been revised to define supplemental oxygen as “low- or high-flow oxygen or other non-invasive ventilation at the start of treatment”.


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