EMA committee recommends 13 medicines for approval in January meeting

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 13 new medications for approval and three therapeutic indication extensions in its January 2021 meeting.

Medicines recommended for approval

The CHMP recommended that AstraZeneca’s COVID-19 Vaccine be granted conditional marketing authorisation to prevent COVID-19 in people from 18 years of age.

The committee gave Seffalair Spiromax (salmeterol/fluticasone) and its duplicate BroPair Spiromax (salmeterol/fluticasone) a positive opinion for the treatment of asthma in adults and adolescents aged 12 years and older.

The committee also recommended granting a marketing authorisation for Byfavo (remimazolam) for procedural sedation.

Kesimpta (ofatumumab) received a positive opinion for the treatment of adult patients with active relapsing forms of multiple sclerosis.

The CHMP suggested Nexpovio (selinexor) should be granted conditional marketing authorisation 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 two anti-epileptic medicinal products.

The committee recommended granting Pemazyre (pemigatinib) a conditional marketing authorisation for the second-line treatment of advanced or metastatic cholangiocarcinoma characterised by fusion or rearrangements of fibroblast growth factor receptor 2.

Sogroya (somapacitan) received a positive opinion as a treatment of growth hormone deficiency in adults.

It was recommended Vazkepa (icosapent ethyl) be granted marketing authorisation to reduce the risk of cardiovascular events in patients at high cardiovascular risk.

Alymsys (bevacizumab) and Oyavas (bevacizumab), two biosimilars, 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 CHMP also gave a positive opinion to the generic medicine Thiotepa Riemser (thiotepa) for use as a conditioning treatment before haematopoietic progenitor cell transplantation.

Three recommendations on extensions of therapeutic indication

The committee recommended that the therapeutic indications of Keytruda, Sirturo and Vaxchora be extended.

In addition, it endorsed addition of a new strength (150 mg), a new pharmaceutical formulation (solution for injection) and a new route of administration (subcutaneous use) for Tysabri, a multiple sclerosis medicine already authorised for intravenous use.

Application withdrawals

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.