Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2017

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10/11/2017

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2017

Ten medicines recommended for approval, including two orphans

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended ten medicines for approval, including two orphan medicines, at its November 2017 meeting.

The CHMP recommended granting a marketing authorisation for Jorveza (budesonide) to treat eosinophilic esophagitis, a rare inflammatory condition of the oesophagus. This medicine was reviewed under EMA’s accelerated assessment mechanism, reserved for medicines of major public health interest. Jorveza has an orphan designation. For more information, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Prevymis (letermovir), an antiviral medicine that prevents cytomegalovirus reactivation and disease in patients who receive immunosuppressant medicines following an allogeneic haematopoietic stem cell transplant. Prevymis has an orphan designation. For more information on this medicine, please see the press release in the grid below.

The CHMP recommended granting a marketing authorisation for Ocrevus (ocrelizumab), for the treatment of adult patients with relapsing multiple sclerosis (RMS) and early primary progressive multiple sclerosis (PPMS). For more information, please see the press release in the grid below.

Adynovi (rurioctocog alfa pegol) received a positive opinion for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A.

The CHMP adopted a positive opinion for Fasenra (benralizumab) for the treatment of severe eosinophilic asthma.

Intrarosa (prasterone) received a positive opinion for the treatment of vulvar and vaginal atrophy in postmenopausal women.

One biosimilar medicine was recommended for approval by the Committee: Mvasi (bevacizumab) for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Three generic medicines received a positive opinion from the CHMP: Darunavir Krka (darunavir) and Darunavir Krka d.d. (darunavir), both for the treatment of human immunodeficiency virus (HIV-1) infection; and Fulvestrant Mylan (fulvestrant), for the treatment of locally advanced or metastatic breast cancer.

Outcome of re-examination of two negative recommendations

The applicants for Fanaptum (iloperidone) and Onzeald (etirinotecan pegol) requested re-examinations of the Committee’s negative opinions for these medicines adopted at the July 2017 meeting. After considering the grounds for these requests, the CHMP re-examined the initial opinions and confirmed its previous recommendations to refuse the granting of marketing authorisations for these medicines.

For more information on these negative opinions, please see the questions-and-answers documents in the grid below.

Four recommendations on extensions of therapeutic indication

The Committee recommended extensions of indications for Adcetris, Genvoya, Nplate and Orkambi.

Outcome of review on Zinbryta

The CHMP concluded its review of the multiple sclerosis medicine Zinbryta (daclizumab) and confirmed further restrictions to reduce the risk of serious liver damage. For more information please see the public health communication in the grid below.

Withdrawals of applications

Applications for initial marketing authorisations for Kyomarc (bevacizumab) and Plivensia (sirukumab) have been withdrawn.

Kyomarc was intended to be used to treat cancer of the colon or rectum, breast cancer, non-small cell lung cancer, kidney cancer, cervical cancer, and cancer of the ovary, the fallopian tube, or the peritoneum.

Plivensia was intended to be used to treat rheumatoid arthritis.

An application to extend the use of Keytruda (pembrolizumab) in metastatic non-squamous NSCLC in combination with chemotherapy has also been withdrawn.

Questions-and-answers documents on these withdrawals are available in the grid below.

Agenda and minutes

The agenda of the November 2017 meeting is published on EMA’s website. Minutes of the October 2017 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the November 2017 CHMP meeting are represented in the graphic below.

More information on all other outcomes of the CHMP November 2017 meeting is available in the grid below.

CHMP_highlights_November_2017

Download image in PDF format

 

Positive recommendations on new medicines

Name of medicineAdynovi
International non-proprietary name (INN)rurioctocog alfa pegol
Marketing-authorisation applicantBaxalta Innovations GmbH
Therapeutic indicationTreatment of haemophilia A
More informationSummary of opinion for Adynovi

 

Name of medicineFasenra
INNbenralizumab
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationTreatment of severe eosinophilic asthma
More informationSummary of opinion for Fasenra

 

Name of medicineIntrarosa
INNprasterone
Marketing-authorisation applicantEndoceutics Ltd
Therapeutic indicationTreatment of vulvar and vaginal atrophy in postmenopausal women
More informationSummary of opinion for Intrarosa

 

Name of medicineJorveza
INNbudesonide
Marketing-authorisation applicantDr. Falk Pharma GmbH
Therapeutic indicationTreatment of eosinophilic esophagitis
More information

Summary of opinion for Jorveza

 

Press release: New medicine for rare inflammatory condition of the oesophagus

 

Name of medicinePrevymis
INNletermovir
Marketing-authorisation applicantMerck Sharp & Dohme Limited
Therapeutic indicationProphylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT)
More information

Summary of opinion for Prevymis

 

Press release: New medicine to prevent cytomegalovirus disease in stem cell transplant patients

 

Name of medicineOcrevus
INNocrelizumab
Marketing-authorisation applicantRoche Registration Limited
Therapeutic indicationTreatment of relapsing forms of multiple sclerosis and primary progressive multiple sclerosis
More information

Summary of opinion for Ocrevus

 

Press release: New medicine for multiple sclerosis

 

Positive recommendations on new generic medicines

Name of medicineDarunavir Krka
INNdarunavir
Marketing-authorisation applicantKrka, d.d., Novo mesto
Therapeutic indicationTreatment of HIV-1 infection
More informationSummary of opinion for Darunavir Krka

 

Name of medicineDarunavir Krka d.d.
INNdarunavir
Marketing-authorisation applicantKrka, d.d., Novo mesto
Therapeutic indicationTreatment of HIV-1 infection
More informationSummary of opinion for Darunavir Krka d.d.

 

Name of medicineFulvestrant Mylan
INNfulvestrant
Marketing-authorisation applicantMylan S.A.S
Therapeutic indicationTreatment of locally advanced or metastatic breast cancer
More informationSummary of opinion for Fulvestrant Mylan

 

Positive recommendation on new biosimilar medicine

Name of medicineMvasi
INNbevacizumab
Marketing-authorisation applicantAmgen Europe B.V.
Therapeutic indicationTreatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix
More informationSummary of opinion for Mvasi

 

Negative recommendations for new medicines following re-examination

Name of medicineFanaptum 
INNiloperidone
Marketing-authorisation applicantVanda Pharmaceuticals Ltd
Therapeutic indicationTreatment of schizophrenia
More informationQuestions and answers on Fanaptum

 

Name of medicineOnzeald
INNetirinotecan pegol
Marketing-authorisation applicantNektar Therapeutics UK Limited
Therapeutic indicationTreatment of advanced breast cancer which has spread to the brain
More informationQuestions and answers on Onzeald

 

Positive recommendations on extensions of indications

Name of medicineAdcetris
INNbrentuximab vedotin
Marketing-authorisation holderTakeda Pharma A/S
More informationSummary of opinion for Adcetris

 

Name of medicineGenvoya
INNelvitegravir / cobicistat / emtricitabine / tenofovir alafenamide
Marketing-authorisation holderGilead Sciences International Limited
More informationSummary of opinion for Genvoya

 

Name of medicineNplate
INNromiplostim
Marketing-authorisation holderAmgen Europe B.V.
More informationSummary of opinion for Nplate

 

Name of medicineOrkambi
INNlumacaftor / ivacaftor
Marketing-authorisation holderVertex Pharmaceuticals (Europe) Ltd
More informationSummary of opinion for Orkambi

 

Public health recommendation

Name of medicineZinbryta
INNdaclizumab
Marketing-authorisation holderBiogen Idec Ltd
More informationPublic health communication on Zinbryta

 

Withdrawals of applications

Name of medicineKyomarc
INNbevacizumab
Marketing-authorisation applicantAmgen Europe B.V.
More informationQuestions and answers on Kyomarc

 

Name of medicinePlivensia
INNsirukumab
Marketing-authorisation applicantJanssen-Cilag International NV
More informationQuestions and answers on Plivensia

 

Withdrawal of extension of indication application

Name of medicineKeytruda
INNpembrolizumab
Marketing-authorisation holderMerck Sharp & Dohme
More informationQuestions and answers on Keytruda

 

Other updates

Scientific advice and protocol assistance

 

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