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.


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Applications for a marketing authorisation for Aduhelm (aducanumab), Miplyffa (arimoclomol) and Neffy (adrenaline) were withdrawn.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 medicineFilsuvez
International non-proprietary name (INN)birch bark extract
Marketing-authorisation applicantAmryt Pharmaceuticals DAC
Therapeutic indicationTreatment of epidermolysis bullosa
More informationFilsuvez: Pending EC decision


Name of medicineLunsumio
Marketing-authorisation applicantRoche Registration GmbH
Therapeutic indicationTreatment of relapsed or refractory follicular lymphoma
More informationLunsumio: Pending EC decision


Name of medicineTabrecta
Marketing-authorisation applicantNovartis Europharm Limited
Therapeutic indicationTreatment of advanced non-small cell lung cancer
More informationTabrecta: Pending EC decision


Positive recommendations on new generic medicine

Name of medicinePirfenidone AET
Marketing-authorisation applicantAlfred E. Tiefenbacher (GmbH & Co. KG)
Therapeutic indicationTreatment of idiopathic pulmonary fibrosis
More informationPirfenidone AET: Pending EC decision


Outcome of re-examination

Name of medicineTecfidera
INNdimethyl fumarate
Marketing-authorisation applicantBiogen Netherlands B.V.
More informationTecfidera: Pending EC decision


Readopted opinion

Name of medicineYselty
INNlinzagolix choline
Marketing-authorisation applicantObsEva Ireland Ltd
Therapeutic indicationTreatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age
More informationYselty: Pending EC decision


Withdrawals of initial marketing authorisation applications

Name of medicineAduhelm
Marketing-authorisation applicantBiogen Netherlands B.V.
Therapeutic indicationTreatment of Alzheimer’s disease
More informationAduhelm: Withdrawn application


Name of medicineNeffy
Marketing-authorisation applicantArs Pharmaceuticals Irl Limited
Therapeutic indicationEmergency treatment of allergic reactions, including anaphylaxis
More informationNeffy: Withdrawn application


Name of medicineMiplyffa
Marketing-authorisation applicantAmryt Pharmaceuticals DAC
Therapeutic indicationTreatment of Niemann-Pick disease type C
More informationMiplyffa : Withdrawn application


Positive recommendations on extensions of indications

Name of medicineBydureon
Marketing-authorisation holderAstraZeneca AB
More informationBydureon: Pending EC decision


Name of medicineElonva
INNcorifollitropin alfa
Marketing-authorisation holderN.V. Organon
More informationElonva: Pending EC decision


Name of medicineKeytruda
Marketing-authorisation holderMerck Sharp & Dohme B.V.
More informationKeytruda: Pending EC decision


Name of medicineNovoSeven
INNeptacog alfa (activated)
Marketing-authorisation holderNovo Nordisk A/S
More informationNovoSeven: Pending EC decision


Name of medicineRetsevmo
Marketing-authorisation holderEli Lilly Nederland B.V.
More informationRetsevmo: Pending EC decision


Name of medicineTecentriq
Marketing-authorisation holderRoche Registration GmbH
More informationTecentriq: Pending EC decision


Name of medicineYescarta
INNaxicabtagene ciloleucel
Marketing-authorisation holderKite Pharma EU B.V.
More informationYescarta: Pending EC decision


Positive recommendations on medicines for use outside the European Union

Name of medicineActrapid
INNinsulin human
More informationActrapid

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


Name of medicineInsulatard
INNinsulin human
More informationInsulatard

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


Start of referral

Name of medicineRubraca
More informationRubraca


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