CHMP's January recommendations: Kesimpta, Ontozry, bevacizumab biosimilars, and more

Regulatory NewsRegulatory News | 01 February 2021 |  By 

The European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA’s CHMP) recommended 13 new medicines for approval when it met in January.
The committee recommended conditional marketing authorization for AstraZeneca’s vaccine against COVID-19 in individuals aged 18 years and up. (RELATED: EMA authorizes AstraZeneca COVID-19 vaccine, Regulatory Focus 29 January 2021).
Teva’s twin formulations, Seffalair Spiromax and Bropair Spiromax (salmeterol/fluticasone), received positive opinions to treat asthma in those aged 12 years and up.
The committee issued a positive opinion for Novartis’ Kesimpta (ofatumumab) for patients with active, relapsing multiple sclerosis. CHMP also recommended that Biogen’s Tysabri (natalizumab) be authorized for subcutaneous use in a new strength and solution for injection. The multiple sclerosis medicine is currently authorized for intravenous use.
An epilepsy medication, Arvelle Therapeutics’ Ontozry (cenobamate), was recommended for authorization in adults with disease inadequately controlled with two or more anti-epileptic drugs.
The ultra-short-acting sedative-hypnotic Paion’s Byfavo (remimazolam) was recommended for authorization to use in procedural sedation.
A once weekly injectible treatment for growth hormone deficiency in adults, Novo Nordisk’s Sogroya (somapacitan) received a positive opinion. The thumbs up from CHMP came after EMA had granted Sogroya orphan designation.
Two oncology drugs, each of which had previously received orphan designation, garnered  recommendations for conditional marketing authorization from CHMP. Karyopharm’s Nexpovio (selinexor) was recommended to treat relapsed and refractory multiple myeloma, while Incyte’s Pemazyre (pemigatinib) got the nod for second-line treatment of advanced or metastatic bile duct cancer with certain gene fusion or rearrangement characteristics.
In other oncology recommendations, two bevacizumab biosimilars, Maxience Research’s Alymsys and Stada’s Oyavas, received positive recommendations to treat certain breast, colorectal, lung, renal cell, ovarian, fallopian tube or peritoneal, and cervical cancers.
Riemser’s generic thiotepa formulation was recommended for use in conditioning before hematopoietic progenitor cell transplantation.
Merck Sharp & Dohme’s Keytruda (pembrolizumab), Janssen-Cilag’s Sirturo (bedaquiline) and Emergent’s live oral cholera vaccine Vaxchora each received recommendations for extended indications.
Finally, Amarin’s Vazkepa (icosapent ethyl) received a favorable opinion to reduce the risk of cardiovascular events in high-risk patients.
The marketing authorization application for Taw Pharma’s formulation of dexamethasone phosphate was withdrawn when the sponsor said it could not remove preservatives from its formulation in timely fashion; the preservatives had not been disclosed in the initial application.
Roche also withdrew its application for Tecentriq (atezolizumab) as first-line treatment for urothelial cancer in combination with cisplatin. The firm’s withdrawal came when EMA shared its provisional opinion that the data did not support effectiveness for this indication.


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