CHMP selects drugs for EU market approval

The Committee supported the very first conditional marketing authorisation for Merck Sharp & Dohme B.V.’s  Ervebo (Ebola Zaire Vaccine (rVSV?G-ZEBOV-GP, live)), for active immunisation adults at risk of infection with the Ebola virus. The recommendation was granted under the EMAs PRIME scheme on the basis of limited clinical Phase III data and reviewed under the Agency’s accelerated assessment programme because of the urgent medical need for a preventive vaccination for the hemorrhagic fever caused by the virus.

The CHMP also recommended granting a marketing authorisation for Eli Lilly Nederland B.V.’s Baqsimi, a first-in-class-intranasal glucagon for patient with severe hypoglycaemia aged four years and older. Severe hypoglycaemia is a serious acute complication of diabetes, which occurs when the level of sugar in the blood drops to a level where the patient becomes confused or unconscious and requires assistance from another person to administer a medicine. As all other EU-approved hypoglycaemia treatments require special preparations before a subcutanous or intramuscular injection, the intranasal application of Baqsimi is a progress, the EMA suggested in a press release.

Quofenix (delafloxacin) from Menarini Industrie Farmaceutiche Riunite s.r.l. received a positive opinion from the CHMP for the treatment of acute bacterial skin and skin structure infections in adults when it is considered inappropriate to use other antibacterial agents

Furthermore, the Committee recommended granting a marketing authorisation for Abvvie’s FDA-approved Jak-1 blocker Rinvoq (upadacitinib) for the treatment of rheumatoid arthritis.

Janssen Pharmaceuticals Inc’s Spravato (esketamine) received a positive opinion for combination treatment in adults with treatment-resistant major depressive disorder.

The biosimilar medicine Pegfilgrastim Mundipharma (pegfilgrastim), intended to reduce the duration of neutropenia (low levels of neutrophils) and the incidence of febrile neutropenia due to chemotherapy, received a positive opinion from the Committee.

Following re-examination, the CHMP recommended granting a marketing authorisation for Evenity (romosozumab), a monoclonal antibody therapy commercialised by Amgen Inc and UCB SA for the treatment of postmenopausal women with severe osteoporosis at high risk of fracture. The Committee had initially adopted a negative opinion for this medicine in June 2019 due to safety concerns. After re-examination, the CHMP granted a positive opinion for a restricted indication. Additional measures and studies are foreseen to follow its use in practice and to ensure that the medicine is used correctly.