Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021

News 12/11/2021

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.

CHMP statistics: November 2021

Positive recommendations on new medicines

Name of medicine Lonapegsomatropin Ascendis Pharma 
International non-proprietary name (INN) lonapegsomatropin
Marketing-authorisation applicant Ascendis Pharma Endocrinology Division A/S
Therapeutic indication Treatment of growth hormone deficiency (GHD) in adolescents and children above 3 years of age
More information Lonapegsomatropin Ascendis Pharma: Pending EC decision

Name of medicine Lumykras
INN sotorasib
Marketing-authorisation applicant Amgen Europe B.V.
Therapeutic indication Treatment of patients with KRAS G12C mutation non-small cell lung cancer
More information Lumykras: Pending EC decision

Name of medicine Regkirona
INN regdanvimab
Marketing-authorisation applicant Celltrion Healthcare Hungary Kft.
Therapeutic indication Treatment of COVID-19
More information

Regkirona: Pending EC decision

News announcement: COVID-19: EMA recommends authorisation of two monoclonal antibody medicines

Name of medicine Ronapreve
INN casirivimab / imdevimab
Marketing-authorisation applicant Roche Registration GmbH
Therapeutic indication Prevention and treatment of COVID-19
More information

Ronapreve: Pending EC decision

News announcement: COVID-19: EMA recommends authorisation of two monoclonal antibody medicines

Name of medicine Tavneos
INN avacopan
Marketing-authorisation applicant Vifor Fresenius Medical Care Renal Pharma France
Therapeutic indication Treatment of adult patients with severe, active granulomatosis with polyangiitis or microscopic polyangiitis
More information

Tavneos: Pending EC decision

News announcement: First-in-class medicine recommended for treatment of rare blood vessel inflammation

Name of medicine Tecovirimat SIGA
INN tecovirimat
Marketing-authorisation applicant SIGA Technologies Netherlands B.V.
Therapeutic indication Treatment of orthopoxvirus disease
More information Tecovirimat SIGA: Pending EC decision

Name of medicine Uplizna
INN inebilizumab
Marketing-authorisation applicant Viela Bio
Therapeutic indication Treatment of adult patients with neuromyelitis optica spectrum disorders
More information Uplizna: Pending EC decision

Name of medicine Voraxaze
INN glucarpidase
Marketing-authorisation applicant Serb
Therapeutic indication Reduction of toxic plasma methotrexate concentration
More information Voraxaze: Pending EC decision

Name of medicine Vyepti
INN eptinezumab
Marketing-authorisation applicant H. Lundbeck A/S
Therapeutic indication Prophylaxis of migraine
More information Vyepti: Pending EC decision

Name of medicine Wegovy
INN semaglutide
Marketing-authorisation applicant Novo Nordisk A/S
Therapeutic indication Treatment of people with obesity or who are overweight in the presence of other related conditions
More information Wegovy: Pending EC decision

Positive recommendations on new informed-consent applications

Name of medicine Riltrava Aerosphere
INN formoterol fumarate dihydrate / glycopyrronium / budesonide
Marketing-authorisation applicant AstraZeneca AB
Therapeutic indication Maintenance treatment of chronic obstructive pulmonary disease
More information Riltrava Aerosphere: Pending EC decision

Negative recommendation on new medicine

Name of medicine Ipique
INN bevacizumab
Marketing-authorisation applicant Rotterdam Biologics B.V.
Therapeutic indication Treatment of neovascular (wet) age-related macular degeneration
More information Ipique: Pending EC decision

Outcomes of re-examinations

Name of medicine Nexviadyme
INN avalglucosidase alfa
Marketing-authorisation applicant Genzyme Europe BV
Therapeutic indication Long-term enzyme replacement therapy for the treatment of patients with Pompe disease
More information Nexviadyme: Pending EC decision

Name of medicine Nouryant
INN istradefylline
Marketing-authorisation applicant Kyowa Kirin Holdings B.V.
Therapeutic indication Treatment of adults with Parkinson’s disease
More information Nouryant: Pending EC decision

Positive recommendations on new therapeutic indications

Name of medicine Dengvaxia
INN dengue tetravalent vaccine (live, attenuated)
Marketing-authorisation holder Sanofi Pasteur
More information Dengvaxia: Pending EC decision

Name of medicine Epclusa
INN sofosbuvir / velpatasvir
Marketing-authorisation holder Gilead Sciences Ireland UC
More information Epclusa: Pending EC decision

Name of medicine Kaftrio
INN ivacaftor / tezacaftor / elexacaftor
Marketing-authorisation holder Vertex Pharmaceuticals (Ireland) Limited
More information Kaftrio: Pending EC decision

Name of medicine Kalydeco
INN ivacaftor
Marketing-authorisation applicant Vertex Pharmaceuticals (Ireland) Limited
More information Kalydeco: Pending EC decision

Name of medicine Noxafil
INN posaconazole
Marketing-authorisation holder Merck Sharp & Dohme B.V.
More information Noxafil: Pending EC decision

Name of medicine Rapiscan
INN regadenoson
Marketing-authorisation holder GE Healthcare AS
More information Rapiscan: Pending EC decision

Re-examination of public-health recommendation

Name of medicine Lidocain / Prilocain Idetec and associated names
INN lidocain / prilocain
More information Referral Art. 29(4): Lidocain/Prilocain Idetec and associated names

Withdrawals of applications

Name of medicine Cervarix
INN human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
More information Cervarix: Withdrawn application

Name of medicine Flynpovi
INN eflornithine / sulindac
More information Flynpovi: Withdrawn application

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