Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 2020

News 13/11/2020

Five new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended five medicines for approval at its November 2020 meeting.

The Committee recommended granting a marketing authorisation for Phesgo (pertuzumab / trastuzumab) for the treatment of early and metastatic breast cancer.

The CHMP adopted a positive opinion for Roclanda (latanoprost / netarsudil) for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction.

Xofluza (baloxavir marboxil) received a positive opinion from the CHMP for the treatment and post-exposure prophylaxis of uncomplicated influenza.

The biosimilar medicine Onbevzi (bevacizumab) received a positive opinion 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.

Positive recommendation on a new medicine following re-examination

The CHMP recommended approving the marketing authorisation for Elzonris* (tagraxofusp), for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive type of acute myeloid leukaemia (blood cancer). The Committee had initially refused the application in July 2020 for Elzonris to be used for the treatment of BPDCN regardless of whether patients had been previously treated with other medicines or not. After re-examination, the CHMP recommended that marketing authorisation under exceptional circumstances could be granted but for a restricted indication in patients who had not yet received any treatment for BPDCN (first-line treatment).

For more information on this positive opinion following re-examination, see the question-and-answer document in the grid below.

Negative recommendation on a new medicine following re-examination

The applicant for Gamifant (emapalumab) requested a re-examination of the Committee's negative opinion adopted at the July 2020 meeting. After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed its previous recommendation to refuse the granting of a marketing authorisation for this medicine, which was intended for the treatment of primary haemophagocytic lymphohistiocytosis (a genetic disease characterised by an overactive immune system) in children under 18 years of age.

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

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Kyprolis, Pradaxa, Tivicay, Trimbow, Xarelto and Xyrem.

Nitrosamines: EMA aligns recommendations for sartans with those for other medicines

The CHMP has aligned recommendations for limiting nitrosamine impurities in sartan medicines with recent recommendations it issued for other classes of medicines. The main change concerns the limits for nitrosamines, which previously applied to the active ingredients but will now apply instead to the finished products (e.g. tablets). These limits, based on internationally agreed standards (ICH M7(R1)), should ensure that the excess risk of cancer from nitrosamines in any sartan medicines is below 1 in 100,000 for a person taking the medicine for lifelong treatment.

For more information, see the public health recommendation in the grid below.

Outcome of review on medicines containing ulipristal acetate 5 mg

The Committee recommended restricting use of medicines containing ulipristal acetate 5 mg (Esmya and generic medicines) as a result of cases of serious liver injury. The medicines can now only be used to treat uterine fibroids in premenopausal women for whom surgical procedures (including uterine fibroid embolisation) are not appropriate or have not worked. The medicines must not be used for controlling symptoms of uterine fibroids while awaiting surgical treatment.

For more information, see the public health recommendation in the grid below.

Withdrawals of applications

Three applications for initial marketing authorisations were withdrawn: Puldysa (idebenone), for the treatment of Duchenne muscular dystrophy; Roctavian (valoctocogene roxaparvovec), for the treatment of severe haemophilia A; and Tibsovo (ivosidenib), for the treatment of acute myeloid leukaemia, a cancer of white blood cells.

Question-and-answer documents on these withdrawals are available in the grid below.

Agenda and minutes

The agenda of the November 2020 meeting is published on EMA's website. Minutes of the October 2020 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the November 2020 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: November 2010

Positive recommendations on new medicines

Name of medicinePhesgo
INNpertuzumab / trastuzumab 
Marketing-authorisation applicantRoche Registration GmbH
Therapeutic indicationTreatment of early and metastatic breast cancer.
More information

Phesgo: Pending EC decision

 

Name of medicineRoclanda
INNlatanoprost / netarsudil
Marketing-authorisation applicantAerie Pharmaceuticals Ireland Limited
Therapeutic indicationReduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction.
More information

Roclanda: Pending EC decision

 

Name of medicineXofluza
INNbaloxavir marboxil 
Marketing-authorisation applicantRoche Registration GmbH
Therapeutic indicationTreatment and post-exposure prophylaxis of uncomplicated influenza.
More informationXofluza: Pending EC decision

 

Positive recommendation on new biosimilar medicine

Name of medicineOnbevzi 
INNbevacizumab
Marketing-authorisation applicantSamsung Bioepis NL 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 informationOnbevzi: Pending EC decision

 

Positive recommendation for new medicine following re-examination

Name of medicineElzonris
INNtagraxofusp
Marketing-authorisation applicantStemline Therapeutics B.V.
Therapeutic indicationTreatment of blastic plasmacytoid dendritic cell neoplasm.
More information

Elzonris: Pending EC decision

PDF iconQuestions and answers on Elzonris  

 

Negative recommendation for new medicine following re-examination

Name of medicineGamifant 
INNemapalumab
Marketing-authorisation applicantSwedish Orphan Biovitrum AB (publ)     
Therapeutic indication

Treatment of primary haemophagocytic lymphohistiocytosis in children under 18 years of age.

More informationGamifant: Pending EC decision

 

Positive recommendations on extensions of indications

Name of medicineKyprolis 
INNcarfilzomib
Marketing-authorisation holderAmgen Europe B.V.
More informationKyprolis: Pending EC decision

 

Name of medicinePradaxa 
INNdabigatran etexilate
Marketing-authorisation holderBoehringer Ingelheim International GmbH
More informationPradaxa: Pending EC decision

 

Name of medicineTivicay
INNdolutegravir
Marketing-authorisation holderViiV Healthcare B.V.
More informationTivicay: Pending EC decision

 

Name of medicineTrimbow
INNbeclometasone / formoterol / glycopyrronium bromide     
Marketing-authorisation holderChiesi Farmaceutici S.p.A
More informationTrimbow: Pending EC decision

 

Name of medicineXarelto
INNrivaroxaban
Marketing-authorisation holderBayer AG
More informationXarelto: Pending EC decision

 

Name of medicineXyrem
INNsodium oxybate 
Marketing-authorisation holderUCB Pharma S.A.
More informationXyrem: Pending EC decision

 

Public-health recommendations

Name of medicineAngiotensin-II-receptor antagonists (sartans) containing a tetrazole group
INNvalsartan, candesartan, irbesartan, losartan and olmesartan
More informationAngiotensin-II-receptor antagonists (sartans) containing a tetrazole group Article-31 referralNitrosamines - EMA aligns recommendations for sartans with those for other medicines

 

Name of medicineUlipristal acetate 5mg medicinal products
INNulipristal acetate 
More informationUlipristal acetate 5mg medicinal products Article-31 referralUlipristal acetate for uterine fibroids: EMA recommends restricting use

 

Withdrawal of initial marketing authorisation applications

Name of medicinePuldysa 
INNidebenone 
Marketing-authorisation applicantSanthera Pharmaceuticals (Deutschland) GmbH
More informationPuldysa: Withdrawn application

 

Name of medicineRoctavian
INNvaloctocogene roxaparvovec
Marketing-authorisation applicantBioMarin International Limited
More informationRoctavian: Withdrawn application

 

Name of medicineTibsovo
INNivosidenib
Marketing-authorisation applicantAgios Netherlands B.V.
More informationTibsovo: Withdrawn application

 

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