From their meeting in September, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
September’s meeting saw seven medicines recommended for approval including three new medicines, one orphan medicine, one biosimilar, one generic and one hybrid medicine.
A conditional marketing authorisation was recommended for two vaccines: MenQuadfi for prophylaxis against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y, and Supemtek for prophylaxis against influenza. CHMP also recommended a marketing authorisation under exceptional circumstances for Obiltoxaximab SFL (obiltoxaximab) for post-exposure prophylaxis of inhalational anthrax.
CHMP adopted a positive opinion for the biosimilar medicine Nyvepria (pegfilgrastim). It will be used to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy. The anticoagulant generic medicine Rivaroxaban Accord (rivaroxaban) and the hybrid medicine Phelinun (melphalan) for treatment of certain haematological and other cancers, also received recommendations for marketing authorisations.
Additionally, there were fifteen recommendations for extensions of therapeutic indications, including Oluminant (baricitinib), Orfadin (nitisinone), Velphoro, Deltyba, Flucelvax Tetra, Fycompa, Lynparza, Opdivo, Symkevi, Tecentriq, Yervoy, Zavicefta, Zejula and two extensions of indication for Kalydeco.
The applicants for two medicines which received negative opinions in July, Elzonris and Gamifant, have requested re-examination of the recommendations. An application for initial marketing authorisation for Upkanz (deferiprone) was withdrawn.
CHMP completed their review of the RECOVERY study which involves dexamethasone in the treatment of hospitalised COVID-19 patients, and concluded that dexamethasone can be considered a treatment option for patients who require oxygen therapy.
A detailed report of the meeting outcomes can be found here.