Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 October 2021

News 15/10/2021

Six new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended six medicines for approval at its October 2021 meeting.

Trodelvy (sacituzumab govitecan) was granted a positive opinion for the treatment of unresectable or metastatic triple-negative breast cancer. See more details in the news announcement in the grid below.

The Committee adopted a positive opinion recommending the granting of a conditional marketing authorisation for Rybrevant (amivantamab) intended for the treatment of non-small cell lung cancer.

The Committee adopted a positive opinion for Aspaveli* (pegcetacoplan) for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria.

The CHMP recommended granting a marketing authorisation for Cibinqo (abrocitinib) for the treatment of atopic dermatitis.

The Committee adopted a positive opinion for Vaxneuvance (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)), intended for prophylaxis against pneumococcal pneumonia and associated invasive disease.

One generic medicine, Sitagliptin SUN (sitagliptin fumarate), was granted a positive opinion by the CHMP for the treatment of type 2 diabetes.

Recommendations on extensions of therapeutic indication for ten medicines

The Committee recommended extensions of indication for Edistride, Forxiga, Hizentra, Kisplyx, Lenvima, Repatha, Skyrizi, Xeljanz, Zeposia and two extensions of indication for Keytruda.

Withdrawal of application

An application for an initial marketing authorisation for Zynyz (retifanlimab) was withdrawn. Zynyz was intended for the treatment of squamous carcinoma of the anal canal, a cancer of the tissues of the anus.

A question-and-answer document on the withdrawal is available in the grid below.

Negative outcome of Article 29 referral on Lidocain/Prilocain Idetec and associated names

The CHMP recommended the refusal of a marketing authorisation for Lidocain/Prilocain Idetec and associated names (lidocaine/prilocaine cream). Lidocain/Prilocain Idetec was intended to be applied to the skin and genital area to prevent pain during minor surgical or medical procedures, and for the treatment of leg ulcers.

For more information on this negative opinion, see the question-and-answer document in the grid below.

Re-election of Bruno Sepodes as CHMP vice-chair

The CHMP re-elected Bruno Sepodes as its vice-chair for a second three-year term, starting in October 2021.

Agenda and minutes

The agenda of the October 2021 CHMP meeting is published on EMA's website. Minutes of the September 2021 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the October 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 highlights Oct 2021

Positive recommendations on new medicines

Name of medicine Aspaveli
International non-proprietary name (INN) pegcetacoplan
Marketing-authorisation applicant Swedish Orphan Biovitrum AB (publ)
Therapeutic indication Treatment of adult patients with paroxysmal nocturnal haemoglobinuria
More information Aspaveli: Pending EC decision

Name of medicine Cibinqo
INN abrocitinib
Marketing-authorisation applicant Pfizer Europe MA EEIG
Therapeutic indication Treatment of atopic dermatitis
More information Cibinqo: Pending EC decision

Name of medicine Rybrevant
INN amivantamab
Marketing-authorisation applicant Janssen-Cilag International N.V.
Therapeutic indication Treatment of non-small cell lung cancer
More information Rybrevant: Pending EC decision

Name of medicine Trodelvy
INN sacituzumab govitecan
Marketing-authorisation applicant Gilead Sciences Ireland UC
Therapeutic indication Treatment of unresectable or metastatic triple-negative breast cancer
More information

Trodelvy: Pending EC decision

News: First-in-class medicine to treat aggressive form of breast cancer

Name of medicine Vaxneuvance
INN pneumococcal polysaccharide conjugate vaccine (adsorbed)
Marketing-authorisation applicant Merck Sharp & Dohme B.V.
Therapeutic indication Prophylaxis against pneumococcal pneumonia and associated invasive disease
More information Vaxneuvance: Pending EC decision

Positive recommendation on new generic medicine

Name of medicine Sitagliptin SUN
INN sitagliptin fumarate
Marketing-authorisation applicant Sun Pharmaceutical Industries Europe B.V.
Therapeutic indication Treatment of type 2 diabetes
More information Sitagliptin SUN: Pending EC decision

Positive recommendations on extensions of indications

Name of medicine Edistride
INN dapagliflozin
Marketing-authorisation holder AstraZeneca AB
More information Edistride: Pending EC decision

Name of medicine Forxiga
INN dapagliflozin
Marketing-authorisation holder AstraZeneca AB
More information Forxiga: Pending EC decision

Name of medicine Hizentra
INN human normal immunoglobulin
Marketing-authorisation holder CSL Behring GmbH
More information Hizentra: Pending EC decision

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

Name of medicine Kisplyx
INN lenvatinib
Marketing-authorisation holder Eisai GmbH
More information Kisplyx: Pending EC decision

Name of medicine Lenvima
INN lenvatinib
Marketing-authorisation holder Eisai GmbH
More information Lenvima: Pending EC decision

Name of medicine Repatha
INN evolocumab
Marketing-authorisation holder Amgen Europe B.V.
More information Repatha: Pending EC decision

Name of medicine Skyrizi
INN risankizumab
Marketing-authorisation holder AbbVie Deutschland GmbH & Co. KG
More information Skyrizi: Pending EC decision

Name of medicine Xeljanz
INN tofacitinib
Marketing-authorisation holder Pfizer Europe MA EEIG
More information Xeljanz: Pending EC decision

Name of medicine Zeposia
INN ozanimod
Marketing-authorisation holder Bristol-Myers Squibb Pharma EEIG
More information Zeposia: Pending EC decision

Referral under Article 29

Name of medicine Lidocain/Prilocain Idetec and associated names
INN lidocaine/prilocaine cream
Applicant International Drug Development France
More information Lidocain/Prilocain Idetec and associated names: Questions and answers

Withdrawal of initial marketing authorisation application

Name of medicine Zynyz
INN retifanlimab
Marketing-authorisation applicant Incyte Biosciences Distribution B.V.
More information Zynyz: Withdrawn application

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