Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 June 2021

News 25/06/2021

Eight new medicines recommended for approval

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

The Committee recommended granting a conditional marketing authorisation for Abecma* (idecabtagene vicleucel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three previous therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment. As Abecma is a gene therapy, the CHMP’s positive opinion is based on an assessment by EMA’s Committee for Advanced Therapies (CAT). See more details in the news announcement in the grid below.

The Committee adopted a positive opinion for Voxzogo* (vosoritide) for the treatment of achondroplasia in patients two years of age and above whose epiphyses are not closed. Achondroplasia is a condition that impairs bone growth and causes dwarfism. See more details in the news announcement in the grid below.

The Committee recommended granting a conditional marketing authorisation for Minjuvi* (tafasitamab) for the treatment of adult patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL) who are not eligible for autologous stem-cell transplant (ASCT).

The Committee adopted a positive opinion, recommending the granting of a marketing authorisation for Bimzelx (bimekizumab) for the treatment of moderate to severe plaque psoriasis.

Byooviz (ranibizumab) was granted a positive opinion by the Committee for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularisation.

Evrenzo (roxadustat) was granted a positive opinion for the treatment of anaemia symptoms in patients with chronic kidney disease.

The CHMP recommended granting marketing authorisations for two generic medicines: Abiraterone Mylan (abiraterone acetate) for the treatment of metastatic prostate cancer and Fingolimod Mylan (fingolimod) for the treatment of relapsing-remitting multiple sclerosis with high disease activity.

Negative recommendation on a new medicine

The CHMP adopted a negative opinion on the marketing authorisation application for Flynpovi (eflornithine / sulindac). Flynpovi was developed as a medicine to treat adults with familial adenomatous polyposis (FAP).

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

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Edistride, Forxiga, Galafold, Opdivo, Rinvoq and Xeljanz.

Withdrawal of application

An application to extend the use of Esbriet (pirfenidone) to include the treatment of unclassifiable interstitial lung disease (UILD) was withdrawn by the company. More information is available in the question-and-answer document in the grid below.

EMA starts review of anxiety medicine Stresam

EMA started a review of Stresam (etifoxine), a medicine authorised in some EU countries for the treatment of anxiety disorders. For more information, see the start-of-referral document in the grid below.

Agenda and minutes

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

CHMP statistics

Key figures from the June 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 June 2021

** This figure was corrected on 12 July 2021 as a withdrawn application for an extension of indication was wrongly counted as a withdrawn application for a new medicine.

***This figure was corrected on 15 July 2021 as a biosimilar product was wrongly counted as a new [non-orphan] medicine.

Positive recommendations on new medicines

Name of medicineAbecma
International non-proprietary name (INN)idecabtagene vicleucel
Marketing-authorisation applicantCelgene Europe BV
Therapeutic indicationTreatment of adult patients with relapsed and refractory multiple myeloma
More information

News announcement:First cell-based gene therapy to treat adult patients with multiple myeloma

Name of medicineBimzelx
INNbimekizumab
Marketing-authorisation applicantUCB Pharma S.A.
Therapeutic indicationTreatment of moderate to severe plaque psoriasis
More information

 

Name of medicineEvrenzo
INNroxadustat
Marketing-authorisation applicantAstellas Pharma Europe B.V.
Therapeutic indicationTreatment of anaemia symptoms in patients with chronic kidney disease
More information

 

Name of medicineMinjuvi
INNtafasitamab
Marketing-authorisation applicantIncyte Biosciences Distribution B.V.
Therapeutic indicationTreatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who are not eligible for autologous stem-cell transplant (ASCT)
More information

 

Name of medicineVoxzogo
INNvosoritide
Marketing-authorisation applicantBioMarin International Limited
Therapeutic indicationTreatment of achondroplasia in patients aged 2 years and above whose epiphyses are not closed
More information

News announcement:New treatment for people with dwarfism

 

Negative recommendation on new medicine

Name of medicineFlynpovi
INNeflornithine / sulindac
Marketing-authorisation applicantCancer Prevention Pharma (Ireland) Limited
Therapeutic indicationTreatment of adult patients with familial adenomatous polyposis
More informationFlynpovi: Pending EC decision

 

Positive recommendation on new biosimilar medicine

Name of medicineByooviz
INNranibizumab
Marketing-authorisation applicantSamsung Bioepis NL B.V.
Therapeutic indicationTreatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularisation
More information

 

Positive recommendations on new generic medicines

Name of medicineAbiraterone Mylan
INNabiraterone acetate
Marketing-authorisation applicantMylan IRE Healthcare Limited
Therapeutic indicationTreatment of metastatic prostate cancer
More information

 

Name of medicineFingolimod Mylan 
INNfingolimod
Marketing-authorisation applicantMylan Ireland Limited
Therapeutic indicationTreatment of relapsing-remitting multiple sclerosis with high disease activity
More information

 

Positive recommendations on extensions of indications

Name of medicineEdistride
INNdapagliflozin
Marketing-authorisation holderAstraZeneca AB
More information

 

Name of medicineForxiga
INNdapagliflozin
Marketing-authorisation holderAstraZeneca AB
More information

 

Name of medicineGalafold
INNmigalastat
Marketing-authorisation holderAmicus Therapeutics Europe Limited
More information

 

Name of medicineOpdivo
INNnivolumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More informationOpdivo: Pending EC decision

 

Name of medicineRinvoq
INNupadacitinib
Marketing-authorisation holderAbbVie Deutschland GmbH & Co. KG
More information

 

Name of medicineXeljanz
INNtofacitinib
Marketing-authorisation holderPfizer Europe MA EEIG
More information

 

Start of referral

Name of medicineStresam
INNetifoxine
More informationEtifoxine-containing medicinal products

Withdrawal of application

Name of medicineEsbriet
INNpirfenidone
More information

Esbriet: Withdrawn application

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