Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021

News 26/03/2021

Five new medicines recommended for approval

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

The Committee recommended granting a marketing authorisation for Copiktra (duvelisib) for the treatment of adults with relapsed or refractory chronic lymphocytic leukaemia (CLL) or refractory follicular lymphoma (FL).

The CHMP adopted a positive opinion for Ponvory (ponesimod) for the treatment of active relapsing forms of multiple sclerosis.

Drovelis and its duplicate Lydisilka, both containing the active substances estetrol and drospirenone, received positive opinions from the Committee for use as oral contraceptives.

The CHMP recommended granting a marketing authorisation for the hybrid medicine Efmody* (hydrocortisone) for the treatment of congenital adrenal hyperplasia (CAH) in patients aged 12 years and over. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Benlysta, Kaftrio, Kalydeco, Saxenda, Tecentriq and Xtandi.

Withdrawal of application

An application to extend the use of Brilique (ticagrelor) with aspirin (acetylsalicylic acid) to prevent problems caused by blood clots in adults with coronary artery disease and type 2 diabetes was withdrawn. A question-and-answer document on this withdrawal is available in the grid below.

COVID-19: Outcome of review on the use of regdanvimab

The CHMP gave a recommendation to define conditions of use for the monoclonal antibody regdanvimab (also known as CT-P59). This medicine is currently not authorised in the EU, but the recommendation provides a harmonised scientific opinion at EU level to support national decision making on the possible use of this antibody to treat confirmed COVID-19 in patients who do not require supplemental oxygen therapy and who are at high risk of progressing to severe COVID-19. See more details in the news announcement in the grid below.

Agenda and minutes

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

CHMP statistics

Key figures from the March 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: March 2021

Positive recommendations on new medicines

Name of medicineCopiktra
International non-proprietary name (INN)duvelisib
Marketing-authorisation applicantVerastem Europe GmbH
Therapeutic indicationTreatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia  (CLL) or refractory follicular lymphoma (FL)
More informationCopiktra: Pending EC decision


Name of medicineDrovelis
International non-proprietary name (INN)estetrol / drospirenone
Marketing-authorisation applicantGedeon Richter Plc.
Therapeutic indicationOral contraception
More informationDrovelis: Pending EC decision


Name of medicineLydisilka
INNestetrol / drospirenone
Marketing-authorisation applicantEstetra SPRL
Therapeutic indicationOral contraception
More informationLydisilka: Pending EC decision


Name of medicinePonvory
Marketing-authorisation applicantJanssen-Cilag International N.V.
Therapeutic indicationTreatment of active relapsing forms of multiple sclerosis
More informationPonvory: Pending EC decision


Positive recommendation on new hybrid medicine

Name of medicineEfmody
Marketing-authorisation applicantDiurnal Europe BV
Therapeutic indicationTreatment of congenital adrenal hyperplasia (CAH) in patients aged 12 years and over
More informationEfmody: Pending EC decision


Positive recommendations on extensions of indication

Name of medicineBenlysta
Marketing-authorisation holder

GlaxoSmithKline (Ireland) Limited

More informationBenlysta: Pending EC decision


Name of medicineKaftrio
INNivacaftor / tezacaftor / elexacaftor
Marketing-authorisation holder

Vertex Pharmaceuticals (Ireland) Limited

More informationKaftrio: Pending EC decision


Name of medicineKalydeco
Marketing-authorisation holder

Vertex Pharmaceuticals (Ireland) Limited

More informationKalydeco: Pending EC decision


Name of medicineSaxenda
Marketing-authorisation holderNovo Nordisk A/S
More informationSaxenda:Pending EC decision


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


Name of medicineXtandi
Marketing-authorisation holder

Astellas Pharma Europe B.V.

More informationXtandi: Pending EC decision


Withdrawal of extension of indication

Name of medicineBrillique
Marketing-authorisation holderAstraZeneca AB
More informationBrillique: Withdrawn application


Opinion on any scientific matter (Article 5(3))

Name of medicineCelltrion use of regdanvimab for the treatment of COVID-19
More informationEMA issues advice on use of regdanvimab for treating COVID-19


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