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Eleven new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eleven medicines for approval at its November 2021 meeting.
Regkirona (regdanvimab) and Ronapreve (casirivimab / imdevimab) are the first monoclonal antibodies to receive a positive opinion by the Committee for the treatment of COVID-19. More details are available in a separate news announcement.
Tavneos* (avacopan) was granted a positive opinion for the treatment of adult patients with severe, active granulomatosis with polyangiitis or microscopic polyangiitis, a rare type of inflammation of the blood vessels. See more details in the news announcement in the grid below.
A positive opinion was adopted for Lonapegsomatropin Ascendis Pharma* (lonapegsomatropin) for the treatment of growth hormone deficiency in adolescents and children above 3 years of age.
The Committee recommended the granting of a conditional marketing authorisation for Lumykras (sotorasib) intended for the treatment of non-small cell lung cancer in patients with a specific mutation, G12C, in the KRAS protein.
A recommendation for a marketing authorisation under exceptional circumstances was adopted for Tecovirimat SIGA (tecovirimat) for the treatment of orthopoxvirus disease.
The CHMP gave a positive opinion for granting a marketing authorisation for Uplizna* (inebilizumab) for the treatment of adult patients with neuromyelitis optica spectrum disorders.
Voraxaze* (glucarpidase), intended to reduce toxic plasma methotrexate concentration in adults and children with delayed methotrexate elimination or at risk of methotrexate toxicity, received a recommendation from the Committee for a marketing authorisation under exceptional circumstances.
The Committee adopted a positive opinion for Vyepti (eptinezumab) for the prophylaxis of migraine in adult patients who have at least 4 migraine days per month.
Wegovy (semaglutide) was granted a positive opinion for weight management in people with obesity or who are overweight and have other related conditions.
The CHMP granted a positive opinion for one informed consent application for the maintenance treatment of chronic obstructive pulmonary disease in adults whose disease is not adequately controlled with other medicines: Riltrava Aerosphere (formoterol fumarate dihydrate / glycopyrronium / budesonide). 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.
Negative recommendation on a new medicine
The CHMP adopted a negative opinion on the marketing authorisation application for Ipique (bevacizumab). The medicine was intended to treat neovascular (wet) age-related macular degeneration.
For more information on this negative opinion, see the question-and-answer document in the grid below.
Recommendations on extensions of therapeutic indication for six medicines
The Committee recommended extensions of indication for Epclusa, Kaftrio, Kalydeco, Noxafil, Rapiscan and two extensions of indication for Dengvaxia.
Re-examinations
The applicant for Lidocain / Prilocain Idetec and associated names (lidocaine / prilocaine cream) has requested a re-examination of the Committee’s opinion for this medicine adopted at its October 2021 meeting. Upon receipt of the grounds of the request, the Agency will re-examine its opinion and issue a final recommendation.
Following a re-examination of its original opinion adopted on Nexviadyme (avalglucosidase alfa), the CHMP confirmed that avalglucosidase alfa is not considered a new active substance. For more information on this re-examination opinion, see the updated summary of opinion in the grid below.
The CHMP also re-examined its original opinion for Nouryant (istradefylline) and confirmed its previous recommendation to refuse the granting of a marketing authorisation for this medicine, which was intended for the treatment of adults with Parkinson’s disease. For more information on this re-examination opinion, see the question-and-answer document in the grid below.
Withdrawals of applications
An application for a marketing authorisation for Flynpovi (eflornithine / sulindac) was withdrawn. Flynpovi was intended for the treatment of familial adenomatous polyposis.
The marketing authorisation holder for Cervarix (human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)) withdrew an application to extend the use of the vaccine to include prevention of head and neck cancers caused by certain types of human papillomavirus in the product information.
Question-and-answer documents on the withdrawals are available in the grid below.
Agenda and minutes
The agenda of the November 2021 CHMP meeting is published on EMA's website. Minutes of the October 2021 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the November 2021 CHMP meeting are represented in the graphic below.
*This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.
Sumber : https://www.ema.europa.eu