EMA's CHMP meeting highlights from September 2020
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EMA’s CHMP meeting highlights from September 2020 Seven new medicines (including two vaccines) were recommended for approval at the recent September meeting of the CHMP,* according to the EMA. In its recent news item about the highlights from this meeting, the following medicines were recommended approval (or issued a positive opinion) by the CHMP, including: • bupivacaine (Exparel) for the treatment of postoperative pain; • meningococcal group A, C, W and Y conjugate vaccine (MenQuadfi) for prevention of invasive meningococcal disease caused by Neisseria meningitides serogroups A, C, W and Y; • recombinant quadrivalent influenza vaccine (Supemtek) for prevention of influenza; • obiltoxaximab (Obiltoxaximab SFL), under exceptional circumstances for the treatment or post-exposure prophylaxis of inhalational anthrax; • a biosimilar pegfilgrastim medicine (Nyvepria) for reducing the duration of neutropenia and incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy; • a generic rivaroxaban medicine (Rivaroxaban Accord) for the treatment and prevention of venous thromboembolism, pulmonary embolism and the prevention of atherothrombotic events in adult patients with various risk factors for such events; and • melphalan (Phelium), a hybrid medicine for treatment of certain haematological and other cancers, and as reduced-intensity conditioning treatment prior to allogeneic haematopoietic stem cell transplantation in adults and children with haematological diseases. In addition, applicants issued negative opinions by the CHMP at its July 2020 meeting for tagraxofusp (Elzonris) and emapalumab (Gamifant) have been granted requests to have the relevant applications re-examined. The CHMP will now re-examine its opinions and issue final recommendations. Fifteen recommendations for extensions of therapeutic indications were also granted by the CHMP – including baricitinib (Olumiant) for the treatment of moderate to severe atopic dermatitis (i.e. the first medicine for this disease severity that patients can take orally), and nitisinone (Orfadin) for the treatment of alkaptonuria (i.e. a rare metabolic disorder with no currently approved medicines available). The CHMP has also concluded its review of results from the RECOVERY study arm involving the use of dexamethasone in the treatment of patients with COVID-19, which "concluded that dexamethasone can be considered a treatment option for patients who require oxygen therapy", said the EMA. The recommendation to suspend all ranitidine-containing medicines in the EU due to the presence of low levels of NDMA** as an impurity was also confirmed by the CHMP. Finally, the application for an initial marketing authorisation for deferiprone (Upkanz) – which was intended for the treatment of pantothenate kinase-associated neurodegeneration (i.e. rare inherited brain disease) – has been withdrawn. * CHMP = Committee for Medicinal Products for Human Use ** NDMA = N-nitrosodimethylamine European Medicines Agency. Meeting highlights from the Committee for Medicinal
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