Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 June 2021
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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.
** 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 medicine | Abecma |
| International non-proprietary name (INN) | idecabtagene vicleucel |
| Marketing-authorisation applicant | Celgene Europe BV |
| Therapeutic indication | Treatment 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 medicine | Bimzelx |
| INN | bimekizumab |
| Marketing-authorisation applicant | UCB Pharma S.A. |
| Therapeutic indication | Treatment of moderate to severe plaque psoriasis |
| More information | Bimzelx: Pending EC decision |
| Name of medicine | Evrenzo |
| INN | roxadustat |
| Marketing-authorisation applicant | Astellas Pharma Europe B.V. |
| Therapeutic indication | Treatment of anaemia symptoms in patients with chronic kidney disease |
| More information | Evrenzo: Pending EC decision |
| Name of medicine | Minjuvi |
| INN | tafasitamab |
| Marketing-authorisation applicant | Incyte Biosciences Distribution B.V. |
| Therapeutic indication | Treatment 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 | Minjuvi: Pending EC decision |
| Name of medicine | Voxzogo |
| INN | vosoritide |
| Marketing-authorisation applicant | BioMarin International Limited |
| Therapeutic indication | Treatment 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 medicine | Flynpovi |
| INN | eflornithine / sulindac |
| Marketing-authorisation applicant | Cancer Prevention Pharma (Ireland) Limited |
| Therapeutic indication | Treatment of adult patients with familial adenomatous polyposis |
| More information | Flynpovi: Questions and answers |
Positive recommendation on new biosimilar medicine
| Name of medicine | Byooviz |
| INN | ranibizumab |
| Marketing-authorisation applicant | Samsung Bioepis NL B.V. |
| Therapeutic indication | 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 |
| More information | Byooviz: Pending EC decision |
Positive recommendations on new generic medicines
| Name of medicine | Abiraterone Mylan |
| INN | abiraterone acetate |
| Marketing-authorisation applicant | Mylan IRE Healthcare Limited |
| Therapeutic indication | Treatment of metastatic prostate cancer |
| More information | Abiraterone Mylan: Pending EC decision |
| Name of medicine | Fingolimod Mylan |
| INN | fingolimod |
| Marketing-authorisation applicant | Mylan Ireland Limited |
| Therapeutic indication | Treatment of relapsing-remitting multiple sclerosis with high disease activity |
| More information | Fingolimod Mylan: 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 | Galafold |
| INN | migalastat |
| Marketing-authorisation holder | Amicus Therapeutics Europe Limited |
| More information | Galafold: Pending EC decision |
| Name of medicine | Opdivo |
| INN | nivolumab |
| Marketing-authorisation holder | Bristol-Myers Squibb Pharma EEIG |
| More information | Opdivo: Pending EC decision |
| Name of medicine | Rinvoq |
| INN | upadacitinib |
| Marketing-authorisation holder | AbbVie Deutschland GmbH & Co. KG |
| More information | Rinvoq: Pending EC decision |
| Name of medicine | Xeljanz |
| INN | tofacitinib |
| Marketing-authorisation holder | Pfizer Europe MA EEIG |
| More information | Xeljanz: Pending EC decision |
Start of referral
| Name of medicine | Stresam |
| INN | etifoxine |
| More information | Etifoxine-containing medicinal products |
Withdrawn of application
| Name of medicine | Esbriet |
| INN | pirfenidone |
| More information |