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Emma. Nine new drugs approved at the March meeting

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Emma.  Nine new drugs approved at the March meeting

Among these is Bimervax, the eighth vaccine approved in Europe against Covid, It can be used as a booster among the over 16s. Green light then for a treatment for relapsing multiple sclerosis; a treatment for moderate to severe active ulcerative colitis; a drug for pediatric use for the prevention of ototoxicity induced by chemotherapy with cisplatin; a treatment of paroxysmal nocturnal hemoglobinuria; and one for the management of refractory edema.

31 MAR

EMA’s CHMP human medicines committee recommended nine medicines for approval at its March 2023 meeting.

The CHMP has recommended authorizing the Covid vaccine Bimervax (formerly Covid HIPRA vaccine) as a booster in people 16 years of age and older who have previously been vaccinated with an mRNA Covid vaccine. It is the eighth vaccine recommended in the European Union (EU) to protect against Covid and, together with already authorized vaccines, will support vaccination campaigns in EU member states during the pandemic.

The committee adopted a positive opinion for Briumvi (ublituximab) for the treatment of relapsing multiple sclerosis, a disease of the brain and spinal cord in which inflammation destroys the protective covering around the nerves and the nerve itself.

Omvoh (mirikizumab) received a positive opinion from the CHMP for the treatment of moderate to severe active ulcerative colitis, an inflammation of the large intestine that causes ulceration and bleeding.

The committee recommended the release of a marketing authorization for pediatric use (cougar) for Pedmarqsi (sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy. Ototoxicity is the development of hearing or balance problems due to a medicine, and cisplatin is a chemotherapy used to treat several types of cancer. Pedmarqsi is indicated in patients aged one month to 18 years with localised, non-metastatic solid tumours.

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The committee adopted a positive opinion for Epysqli (eculizumab), a biosimilar medicines for the treatment of paroxysmal nocturnal haemoglobinuria, a rare disease which leads to the premature destruction and impaired production of blood cells.

The CHMP has given a positive opinion to Qaialdo (spironolactone) for the management of refractory edema, a persistent swelling that is unresponsive to diuretic use and sodium restriction. This medicinal product was submitted as a hybrid application, which is based in part on the results of preclinical tests and clinical trials of an already authorized reference product and partly on new data.

The committee adopted positive opinions for three generic medicines:

Recommendations on the extension of therapeutic indication for six medicines

The committee recommended six extensions of the indication for medicines already authorized in the EU: Breyanzi, between and its duplicate Neparvis, Gossip, Ultomiris e Wegs.

Per Ultomiristhe committee also recommended a new one route of administration with a new force and pharmaceutical form.

Withdrawals of questions

Three questions of marketing authorisation have been withdrawn:

  • Ferahemintended intravenous treatment of iron deficiency anemia.
  • Onteeointended to the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis and Covid.
  • Raltegravir Viatrisintended for the treatment of human immunodeficiency virus (HIV-1) infection.

Feraheme and Raltegravir Viatris withdrawal Q&A documents can be found in the grid below. Onteeo is a duplicate of a medicine currently under evaluation.

March 31, 2023
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