The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended 13 new medicines for approval in its latest meeting.
This includes AstraZeneca’s COVID-19 vaccine – the CHMP has recommended granting the jab a conditional marketing authorisation for use in people aged 18 years and older.
Novartis’ multiple sclerosis (MS) treatment Kesimpta (ofatumumab) received a positive opinion for the treatment of patients with active relapsing forms of MS.
Amarin’s heart failure drug Vazkepa (icosapent ethyl) was also handed a recommendation for a conditional marketing authorisation to reduce the risk of cardiovascular events in high risk patients.
The CHMP also recommended granting a conditional marketing authorisation for Karyopharm’s Nexpovio (selinexor) for the treatment of relapsed or refractory myeloma.
Meanwhile, Arvelle Therapeutics’ Ontozry (cenobamate) has been recommended for the treatment of adults with epilepsy, whose disease is not adequately controlled.
PAION’s Byfavo (remimazolam) scored a positive opinion for use in procedural sedation, with the CHMP also recommending Inctye’s Pemazyre (pemigatinib) for the second-line treatment of advanced/metastatic cholangiocarcinoma (bile duct cancer).
In addition, Novo Nordisk’s Sogroya (somapacitan) was recommended for use in the treatment of growth hormone deficiency in adults.
The CHMP also recommended Teva’s Seffalair Spiromax (salmeterol/fluticasone) and its duplicate BroPair Spiromax (salmeterol/fluticasone) for the treatment of asthma.
Two biosimilar medicines were also recommended in the latest meeting, including Mabxience Research’s Alymsys (bevacizumab) and STADA’s Oyavas (bevacizumab), for the treatment of a number of cancer types.
A generic medicine – Thiotepa Riemser (thiotepa) – also received a positive opinion for use as a conditioning treatment before haematopoietic progenitor cell transplantation.
The CHMP also recommended indication extensions for MSD’s Keytruda (pembrolizumab), Janssen’s Sirturo (bedaquiline) and Emergent’s cholera vaccine Vaxchora.