CHMP Recommends 15 Medicines, Extends Six Indications

Regulatory NewsRegulatory News | 31 January 2020 |  By 

At its first meeting in 2020, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of eight new medicines, six generic and hybrid applications and a biosimilar.
The eight new medicines include Alnylam’s Givlaari (givosiran), the first treatment for acute hepatic porphyria in adults and children 12 and older. Givlaari was granted orphan designation and accepted to EMA’s PRIority MEdicine (PRIME) scheme, which EMA says “led to a more robust application package to demonstrate the medicine’s benefits and risks.”
The other new medicines include Novo Nordisk’s type 2 diabetes drug Rybelsus (semaglutide), Emergent’s cholera vaccine Vaxchora (Cholera vaccine (recombinant, live, oral)), Eli Lilly’s diabetes mellitus drug Liumjev (insulin lispro), Esperion’s primary hypercholesterolemia and mixed dyslipidemia drugs Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/exetimibe), Bayer’s prostate cancer drug Nubeqa (darolutamide) and Pfizer’s atopic dermatitis treatment Staquis (crisaborole).
CHMP also recommended Pfizer’s biosimilar Ruxience (rituximab) and four generic medicines, Azacitidine betapharm (azacytidine), Azacitidine Mylan (azacitidine), Arsenic trioxide Mylan (arsenic trioxide) and Cinacalcet Accordpharma (cinacalcet).
Extended indications were recommended for six medicines: Biofrontera’s Ameluz (5-aminolevulinic acid hydrochloride), Roche’s MabThera (rituximab), Janssen’s Rezolsta (darunavir and cobicistat), Sanofi’s Suliqua (insulin glargine and lixisenatide), Gilead’s Tybost (cobicistat) and AbbVie’s Venclyxto (venetoclax).
Additionally, CHMP recommended the marketing authorization of two hybrid medicines, Budesonide/Formoterol Teva Pharma B.V. (budesonide / formoterol fumarate dihydrate) and Trepulmix (treprostinil sodium). In the EU, hybrid applications are similar to 505(b)(2) submissions in the US, which allow for drugmakers to rely in part on studies conducted by other companies to support a drug’s approval.
CHMP also said that two marketing authorization applications were withdrawn from consideration ahead of the meeting, Merck’s application to extend the use of Keytruda (pembrolizumab) to treat esophageal cancer and Celgene and Agios’ application for Idhifa (enasidenib) to treat acute myeloid leukemia.
Separately, Bristol-Myers Squibb said on Friday it has withdrawn its application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of advanced non-small cell lung cancer, noting that CHMP “determined a full assessment of the application was not possible following multiple protocol changes the company made.”


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