Thirteen new medicines recommended for approval.
EMA’s human medicines committee (CHMP) recommended 13 medicines for approval at its January 2021 meeting.
The Committee recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca (COVID-19 Vaccine (ChAdOx1-S [recombinant])) to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age. This is the third COVID-19 vaccine that EMA has recommended for authorisation. For more information, see the press release in the grid below.
Seffalair Spiromax (salmeterol / fluticasone) and its duplicate BroPair Spiromax (salmeterol / fluticasone) received a positive opinion for the treatment of asthma in adults and adolescents aged 12 years and older.
The Committee recommended granting a marketing authorisation for Byfavo (remimazolam) for procedural sedation.
Kesimpta (ofatumumab) received a positive opinion from the Committee for the treatment of adult patients with active relapsing forms of multiple sclerosis.
The CHMP recommended granting a conditional marketing authorisation for Nexpovio* (selinexor) for the treatment of relapsed and refractory multiple myeloma.
Ontozry (cenobamate) received a positive opinion for the treatment of adults with epilepsy whose disease is not adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.
The Committee recommended granting a conditional marketing authorisation for Pemazyre* (pemigatinib) for the second-line treatment of advanced or metastatic cholangiocarcinoma (bile duct cancer) characterized by fusion or rearrangements of fibroblast growth factor receptor 2.
Sogroya* (somapacitan) received a positive opinion from the CHMP for the treatment of growth hormone deficiency in adults.
The Committee recommended granting a marketing authorisation for Vazkepa (icosapent ethyl) to reduce the risk of cardiovascular events in patients at high cardiovascular risk.
Two biosimilar medicines, Alymsys (bevacizumab) and Oyavas (bevacizumab), received a positive opinion for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
The generic medicine Thiotepa Riemser (thiotepa) received a positive opinion for use as a conditioning treatment before haematopoietic progenitor cell (cells that make blood cells) transplantation.
Three recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Keytruda, Sirturo and Vaxchora.
The CHMP also recommended the addition of a new strength (150 mg), a new pharmaceutical form (solution for injection) and a new route of administration (subcutaneous use) for Tysabri, a multiple sclerosis medicine already authorised for intravenous use.
Clarification of Comirnaty dosage interval
The CHMP has updated the product information for the COVID-19 vaccine Comirnaty to clarify its position on the interval between the first and second dose. The product information (section 4.2 and package leaflet) now recommends the administration of the second dose 3 weeks after the first dose. Previously, the product information stated that the interval should be “at least 21 days”.
For more information, see the communication published on 28 January 2021 on EMA’s website.
Withdrawals of applications
The application for an initial marketing authorisation for Dexamethasone Taw (dexamethasone phosphate) was withdrawn. This medicine was intended for the treatment of several inflammatory and other conditions.
The application to extend the use of Tecentriq (atezolizumab) to treat advanced or metastatic urothelial cancer in combination with platinum-based therapy in patients who had not been treated before was also withdrawn.
Exceptionally, due to the extended meeting timetable, most of the associated documents will only become available from Monday 1 February 2021.
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