The European Medicines Agency (EMA)’s human medicines committee (CHMP) has recommended fifteen medicines for approval at its first meeting of 2020, as well as six extensions of current indications.
First up, the committee recommended a marketing authorisation for Alnylam’s Givlaari (givosiran), the first treatment for acute hepatic porphyria in adults and adolescents aged 12 years and older.
The drug was supported by the PRIME scheme, which assists developers of promising new medicines that address unmet medical needs.
The committee also adopted a positive opinion for Rybelsus (semaglutide), Novo Nordisk’s treatment for adults with insufficiently controlled type II diabetes to improve glycaemic control as an adjunct to diet and exercise.
Novo Nordisk responded to the decision, saying it is “very excited” about the positive opinion “as it is the first and only GLP-1 in a tablet, and we believe it has the potential to set a new standard for the treatment of type II diabetes in the EU,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer.
Next, the committee recommended granting a marketing authorisation for Emergent’s Vaxchora (Cholera vaccine (recombinant, live, oral)) for prophylaxis against cholera, a disease caused by Vibrio cholerae, in adults and children.
Among the other recommendations were Eli Lilly’s Liumjev (insulin lispro) for diabetes mellitus, FGK’s Nilemdo (bempedoic acid) and Nustendi (bempedoic acid / ezetimibe) for the treatment of primary hypercholesterolaemia and Nubeqa (darolutamide) – Bayer’s drug for the treatment of prostate cancer.
Also in the long list of decisions was a positive opinion for Pfizer with both Staquis (crisaborole), its medicine for the treatment of atopic dermatitis, and Ruxience (rituximab) for the treatment of non-Hodgkin’s lymphoma, and chronic lymphocytic leukaemia among others.
Recommendations went to four generic medicines too, Azacitidine betapharm (azacytidine), Azacitidine Mylan (azacitidine) Arsenic trioxide Mylan (arsenic trioxide), and Cinacalcet Accordpharma (cinacalcet).
Finally, the committee recommended extensions of indication for Ameluz (5-aminolevulinic acid), MabThera (rituximab), Rezolsta (darunavir/cobicistat), Suliqua (insulin glargine/lixisenatide), Tybost (cobicistat) and Venclyxto (venetoclax).
Further information is available on the CHMP’s website.
