CHMP recommends 11 new medicines for authorization, including two COVID-19 monoclonal antibodies

Regulatory NewsRegulatory News | 16 November 2021 |  By 

The European Medicine Agency’s (EMA) Committee for Medicinal Products (CHMP)  last week recommended 11 new medicines for approval in the EU, including Europe’s first two new monoclonal antibodies for treating COVID-19. The agency also recommended the rejection of a treatment for neovascular (wet) age-related macular degeneration.
CHMP recommended authorizing Celltrion Healthcare Hungary’s Regkirona (regdanvimab) and Roche’s Ronapreve (casirivimab/imdevimab) for treating COVID-19 in adults who do not require supplemental oxygen and are at increased risk of severe disease, according to a separate announcement. Ronapreve was also recommended for adolescents aged 12 years and up who weigh at least 40 kg. The agency noted that these medicines “are the first monoclonal antibodies to receive a positive opinion by the Committee for the treatment of COVID-19.”
They join other products that have received positive opinions for treating COVID since Veklury (remdesivir) was recommended for approval in June 2020. (RELATED: COVID-19 therapeutics tracker, Regulatory Focus 5 November 2021).
In other treatment areas, Vifor Fresenius’s Tavneos (avacopan) was recommended for the treatment of adult patients with active and severe granulomatosis with polyangiitis, formerly called Wegener’s granulomatosis, and microscopic polyangiitis. Tavneos is a first-in-class medicine to treat the two rare forms of autoimmune vasculitis.
Ascendis Pharma Endocrinology’s Skytrofa (lonapegsomatropin) received a positive opinion for treating growth hormone deficiency in adolescents and children over 3 years of age.
Amgen Europe’s Lumykras (sotorasib) was recommended for conditional marketing approval for treating non-small cell lung cancer in patients with a G12C KRAS protein mutation.
Siga Technologies Netherland’s Tecovirimat SIGA (tecovirimat) received a recommendation for marketing authorization under exceptional circumstances to treat orthopoxvirus disease. This designation is reserved for cases where the applicant cannot provide full efficacy and safety data either because a disease is rare, or it would be unethical to conduct such a trial.
The committee handed out another marketing authorization under exceptional circumstances to BTG Specialty Pharmaceutical’s Voraxaze (glucarpidase) to “reduce toxic plasma methotrexate concentration in adults and children with delayed methotrexate elimination or at risk of methotrexate toxicity.”
The committee recommended a marketing authorization for Viela Bio’s Uplizna (inebilizumab) for treating adults with neuromyelitis optica spectrum disorders.
H. Lundbeck received the green light for its Vyepti (eptinezumab) for preventing migraines in adults who have at least four migraine episodes a month.
Novo Nordisk was granted a positive opinion for Wegovy (semaglutide) for weight management in patients with obesity.
Lastly, AstraZeneca was granted a positive opinion for its informed consent application for Riltrava Aerosphere (formoterol fumarate dihydrate/glycopyrronium/budesonide) for treating chronic obstructive pulmonary disease in adults whose disease is not adequately controlled by other medications. An informed consent application “makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application,” explained EMA in the update.
Negative opinions
CHMP also recommended that Rotterdam Biologics Ipique (bevacizumab) application be refused and issued a negative opinion for its treatment of neovascular (wet) age-related macular degeneration. The primary basis for the negative decision was the sponsor’s lack of data comparing intravitreal injection of Ipique to injection of another bevacizumab formulation.
Vertex’s Kaftrio (ivacaftor/tezacaftor/elexacaftor), Vertex’s Kalydeco (ivacaftor), Merck’s Noxafil (Posaconazole), GE Healthcare’s Rapiscan (regadenoson), Sanofi Pasteur’s Dengvaxia and Gilead Sciences Ireland’s Epclusa were recommended for extensions of indication.
In other areas, the applicant for Lidocain/Prilocain Idetec (lidocaine/prilocaine cream) has requested a re-examination of the Committee’s opinion for its medicine adopted at its October meeting. “Upon receipt of the grounds of the request, the agency will re-examine its opinion and issue a final recommendation,” wrote CHMP. The medicine is to treat pain following minor surgical or medical procedures and to treat leg ulcers. On 14 October, the agency concluded that the applicant had not provided sufficient evidence of equivalency to the reference product.
Also, following a re-examination of its original opinion adopted on Sanofi’s Nexviadyme (avalglucosidase alfa), the CHMP confirmed that “avalglucosidase alfa is not considered a new active substance.”   
In re-examining its opinion on Kyowa Kirin’s Nouryant (istradefylline), CHMP again decided that studies supporting its use in Parkinson’s disease were “inconsistent;” only half of the studies showed a reduction in ‘off’ time with Nouryant, and no dose-response effect was seen.
Withdrawals announced
EMA also announced that Cancer Prevention Pharma of Ireland has withdrawn its marketing authorization application for Flynpovi (eflornithine/sulindac) to treat adults with familial adenomatous polyposis.
GlaxoSmithKline also withdrew its application for Cerbarix (human papillomavirus vaccine types 16 and 18) to extend the use of the vaccine for preventing head and neck cancers caused by certain types of the human papillomavirus.
EMA announcement


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