Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2022

News 22/04/2022

Four new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended four medicines for approval in the European Union (EU) at its April 2022 meeting.

The CHMP gave a positive opinion for Filsuvez* (birch bark extract) for the treatment of epidermolysis bullosa.

Lunsumio* (mosunetuzumab) received a positive opinion from the CHMP for a conditional marketing authorisation for the treatment of relapsed or refractory (when treatment does not work) follicular lymphoma.

A positive opinion was adopted for Tabrecta (capmatinib) for the treatment of advanced non-small cell lung cancer.

A generic medicine, Pirfenidone AET (pirfenidone), received a positive opinion from the Committee for the treatment of idiopathic pulmonary fibrosis.

Recommendations on extensions of therapeutic indication for seven medicines

The Committee recommended seven extensions of indication for medicines that are already authorised in the EU: Bydureon, Elonva, Keytruda, NovoSeven, Retsevmo, Tecentriq and Yescarta.

Facilitating global access to diabetes treatments

The CHMP has given a recommendation for two diabetes mellitus treatments, Actrapid (insulin human) and Insulatard (insulin human), for use outside the EU.

The two diabetes medicines were submitted to EMA under a regulatory procedure (Article 58 of Regulation (EC) No 726/2004) known as EU-Medicines for all (EU-M4All) that enables the Agency to support global regulatory capacity building and contribute to the protection and promotion of public health beyond the EU. See more details in the news announcement in the grid below.

Re-examination

Following a re-examination, the CHMP confirmed its original recommendation for Tecfidera (dimethyl fumarate), initially adopted on 27 January 2022. See more details in the summary of opinion in the grid below.

Revised opinion

The Committee adopted a revised opinion for Yselty (linzagolix choline) after further safety information emerged during the decision-making process.

Three withdrawals of application

Applications for a marketing authorisation for Aduhelm (aducanumab), Miplyffa (arimoclomol) and Neffy (adrenaline) were withdrawn. Aduhelm, for which a re-examination of a previous negative recommendation was ongoing at the time of withdrawal, was intended for the treatment of Alzheimer’s disease; Miplyffa was intended for the treatment of Niemann-Pick disease type C; and Neffy was intended for the emergency treatment of allergic reactions, including anaphylaxis.

Question-and-answer documents on the withdrawals are available in the grid below.

Start of referral

The CHMP started a review of all available information on the benefits and risks of the cancer treatment Rubraca (rucaparib) in patients with cancer of the ovary, fallopian tubes or peritoneum with a BRCA mutation whose cancer has come back after platinum-based chemotherapy and who can no longer have these medicines. The review follows a planned interim analysis of a post-approval study that raised concerns regarding the benefit of the medicine in this indication. The review is carried out under Article 20 of Regulation (EC) No 726/2004. The CHMP further agreed as a temporary measure that physicians are recommended not to start new patients on rucaparib in the above indication while the review is ongoing. For more information, see the Public Health Communication in the grid below.

Agenda and minutes

The agenda of the April 2022 CHMP meeting is published on EMA's website. Minutes of the March 2022 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the April 2022 CHMP meeting are represented in the graphic below.

CHMP highlights April 2022


*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.

Positive recommendations on new medicines

Name of medicine Filsuvez
International non-proprietary name (INN) birch bark extract
Marketing-authorisation applicant Amryt Pharmaceuticals DAC
Therapeutic indication Treatment of epidermolysis bullosa
More information Filsuvez: Pending EC decision

Name of medicine Lunsumio
INN mosunetuzumab
Marketing-authorisation applicant Roche Registration GmbH
Therapeutic indication Treatment of relapsed or refractory follicular lymphoma
More information Lunsumio: Pending EC decision

Name of medicine Tabrecta
INN capmatinib
Marketing-authorisation applicant Novartis Europharm Limited
Therapeutic indication Treatment of advanced non-small cell lung cancer
More information

Positive recommendations on new generic medicine

Name of medicine Pirfenidone AET
INN pirfenidone
Marketing-authorisation applicant Alfred E. Tiefenbacher (GmbH & Co. KG)
Therapeutic indication Treatment of idiopathic pulmonary fibrosis
More information Pirfenidone AET: Pending EC decision

Outcome of re-examination

Name of medicine Tecfidera
INN dimethyl fumarate
Marketing-authorisation applicant Biogen Netherlands B.V.
More information Tecfidera: Pending EC decision

Readopted opinion

Name of medicine Yselty
INN linzagolix choline
Marketing-authorisation applicant ObsEva Ireland Ltd
Therapeutic indication Treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age
More information Yselty: Pending EC decision

Withdrawals of initial marketing authorisation applications

Name of medicine Aduhelm
INN aducanumab
Marketing-authorisation applicant Biogen Netherlands B.V.
Therapeutic indication Treatment of Alzheimer’s disease
More information Aduhelm: Withdrawn application

Name of medicine Neffy
INN epinephrine
Marketing-authorisation applicant Ars Pharmaceuticals Irl Limited
Therapeutic indication Emergency treatment of allergic reactions, including anaphylaxis
More information Neffy: Withdrawn application

Name of medicine Miplyffa
INN arimoclomol
Marketing-authorisation applicant Amryt Pharmaceuticals DAC
Therapeutic indication Treatment of Niemann-Pick disease type C
More information Miplyffa : Withdrawn application

Positive recommendations on extensions of indications

Name of medicine Bydureon
INN exenatide
Marketing-authorisation holder AstraZeneca AB
More information

Name of medicine Elonva
INN corifollitropin alfa
Marketing-authorisation holder N.V. Organon
More information Elonva: 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 NovoSeven
INN eptacog alfa (activated)
Marketing-authorisation holder Novo Nordisk A/S
More information

Name of medicine Retsevmo
INN selpercatinib
Marketing-authorisation holder Eli Lilly Nederland B.V.
More information

Name of medicine Tecentriq
INN atezolizumab
Marketing-authorisation holder Roche Registration GmbH
More information

Name of medicine Yescarta
INN axicabtagene ciloleucel
Marketing-authorisation holder Kite Pharma EU B.V.
More information

Positive recommendations on medicines for use outside the European Union

Name of medicine Actrapid
INN insulin human
More information Actrapid

News announcement: Facilitating global access to diabetes treatments for non-EU patients (22/04/2022)

Name of medicine Insulatard
INN insulin human
More information Insulatard

News announcement: Facilitating global access to diabetes treatments for non-EU patients (22/04/2022)

Start of referral

Name of medicine Rubraca
INN rucaparib
More information Rubraca

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