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 statistics: November 2017

Positive recommendations on new medicines

Name of medicine	Adynovi
International non-proprietary name (INN)	rurioctocog alfa pegol
Marketing-authorisation applicant	Baxalta Innovations GmbH
Therapeutic indication	Treatment of haemophilia A
More information	CHMP summary of positive opinion for Adynovi

Name of medicine	Fasenra
INN	benralizumab
Marketing-authorisation applicant	AstraZeneca AB
Therapeutic indication	Treatment of severe eosinophilic asthma
More information	CHMP summary of positive opinion for Fasenra

Name of medicine	Intrarosa
INN	prasterone
Marketing-authorisation applicant	Endoceutics Ltd
Therapeutic indication	Treatment of vulvar and vaginal atrophy in postmenopausal women
More information	CHMP summary of positive opinion for Intrarosa

Name of medicine	Jorveza
INN	budesonide
Marketing-authorisation applicant	Dr. Falk Pharma GmbH
Therapeutic indication	Treatment of eosinophilic esophagitis
More information	CHMP summary of positive opinion for Jorveza Press release: New medicine for rare inflammatory condition of the oesophagus

Name of medicine	Prevymis
INN	letermovir
Marketing-authorisation applicant	Merck Sharp & Dohme Limited
Therapeutic indication	Prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT)
More information	CHMP summary of positive opinion for Prevymis Press release: New medicine to prevent cytomegalovirus disease in stem cell transplant patients

Name of medicine	Ocrevus
INN	ocrelizumab
Marketing-authorisation applicant	Roche Registration Limited
Therapeutic indication	Treatment of relapsing forms of multiple sclerosis and primary progressive multiple sclerosis
More information	CHMP summary of positive opinion Ocrevus Press release: New medicine for multiple sclerosis

Positive recommendations on new generic medicines

Name of medicine	Darunavir Krka
INN	darunavir
Marketing-authorisation applicant	Krka, d.d., Novo mesto
Therapeutic indication	Treatment of HIV-1 infection
More information	CHMP summary of positive opinion for Darunavir Krka

Name of medicine	Darunavir Krka d.d.
INN	darunavir
Marketing-authorisation applicant	Krka, d.d., Novo mesto
Therapeutic indication	Treatment of HIV-1 infection
More information	CHMP summary of positive opinion for Darunavir Krka d.d.

Name of medicine	Fulvestrant Mylan
INN	fulvestrant
Marketing-authorisation applicant	Mylan S.A.S
Therapeutic indication	Treatment of locally advanced or metastatic breast cancer
More information	CHMP summary of positive opinion for Fulvestrant Mylan

Positive recommendation on new biosimilar medicine

Name of medicine	Mvasi
INN	bevacizumab
Marketing-authorisation applicant	Amgen Europe B.V.
Therapeutic indication	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
More information	CHMP summary of positive opinion for Mvasi

Negative recommendations for new medicines following re-examination

Name of medicine	Fanaptum
INN	iloperidone
Marketing-authorisation applicant	Vanda Pharmaceuticals Ltd
Therapeutic indication	Treatment of schizophrenia
More information	Questions and answers on the refusal of the marketing authorisation for Fanaptum (iloperidone)

Name of medicine	Onzeald
INN	etirinotecan pegol
Marketing-authorisation applicant	Nektar Therapeutics UK Limited
Therapeutic indication	Treatment of advanced breast cancer which has spread to the brain
More information	Questions and answers on the refusal of the marketing authorisation for Onzeald (etirinotecan pegol)

Positive recommendations on extensions of indications

Name of medicine	Adcetris
INN	brentuximab vedotin
Marketing-authorisation holder	Takeda Pharma A/S
More information	CHMP post-authorisation summary of positive opinion for Adcetris (II-48)

Name of medicine	Genvoya
INN	elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide
Marketing-authorisation holder	Gilead Sciences International Limited
More information	CHMP post-authorisation summary of positive opinion for Genvoya (II-26)

Name of medicine	Nplate
INN	romiplostim
Marketing-authorisation holder	Amgen Europe B.V.
More information	CHMP post-authorisation summary of positive opinion for Nplate

Name of medicine	Orkambi
INN	lumacaftor / ivacaftor
Marketing-authorisation holder	Vertex Pharmaceuticals (Europe) Ltd
More information	CHMP post-authorisation summary of positive opinion for Orkambi (X-20)

Public health recommendation

Name of medicine	Zinbryta
INN	daclizumab
Marketing-authorisation holder	Biogen Idec Ltd
More information	Public health communication on Zinbryta

Withdrawals of applications

Name of medicine	Kyomarc
INN	bevacizumab
Marketing-authorisation applicant	Amgen Europe B.V.
More information	Questions and answers on the withdrawal of the marketing authorisation application for Kyomarc (bevacizumab)

Name of medicine	Plivensia
INN	sirukumab
Marketing-authorisation applicant	Janssen-Cilag International NV
More information	Questions and answers on the withdrawal of the marketing authorisation application for Plivensia (sirukumab)

Withdrawal of extension of indication application

Name of medicine	Keytruda
INN	pembrolizumab
Marketing-authorisation holder	Merck Sharp & Dohme
More information	Questions and answers on the withdrawal of the marketing authorisation application for Keytruda (pembrolizumab)

Other updates

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 6-9 November 2017

Scientific advice and protocol assistance adopted during the CHMP meeting 6 – 9 November 2017