Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020

News 24/07/2020

Eleven new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended eleven medicines for approval at its July 2020 meeting, including a medicine for use in countries outside the European Union.

The CHMP adopted a positive opinion for Dapivirine Vaginal Ring (dapivirine) used to reduce the risk of infection with the human immunodeficiency virus type 1 (HIV-1), in combination with safer sex practices when oral pre-exposure prophylaxis is not used, cannot be used or is not available. Placed in the vagina, the ring slowly releases the antiretroviral medicine dapivirine over a period of 28 days.

This is the eleventh medicine recommended by EMA under EU Medicines for all (EU-M4All), a mechanism that allows the CHMP to assess and give opinions on medicines that are intended for use in countries outside the EU under Article 58 of Regulation (EC) No 726/2004. For more information, see the press release in the grid below.

The Committee recommended granting a conditional marketing authorisation for Blenrep* (belantamab mafodotin), a new antibody-drug conjugate for adult patients with relapsed and refractory multiple myeloma who no longer respond to treatment with an immunomodulatory agent, a proteasome inhibitor and a CD-38 monoclonal antibody. Blenrep benefited from the support of the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs. For more information, see the press release in the grid below.

The CHMP recommended granting a marketing authorisation for Adakveo* (crizanlizumab), for the prevention of recurrent vaso-occlusive crises (when blood vessels are blocked by abnormal red blood cells, restricting the flow of blood to an organ) in patients with sickle cell disease.

The CHMP adopted a positive opinion for Arikayce liposomal* (amikacin), for the treatment of non-tuberculous mycobacterial lung infections caused by Mycobacterium avium Complex in adults with limited treatment options who do not have cystic fibrosis.

The Committee recommended granting a conditional marketing authorisation for Ayvakyt* (avapritinib), for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours harbouring the platelet-derived growth factor receptor alpha D842V mutation.

The Committee adopted a positive opinion for Calquence* (acalabrutinib) for the treatment of chronic lymphocytic leukaemia, a type of cancer affecting white blood cell called lymphocytes.

Jyseleca (filgotinib) received a positive opinion for the treatment of rheumatoid arthritis.

The CHMP recommended granting a marketing authorisation for Zynrelef (bupivacaine / meloxicam) for the treatment of post-operative pain.

The biosimilar medicine Equidacent (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.

The CHMP recommended granting marketing authorisations for two generic medicines: Arsenic trioxide medac (arsenic trioxide), for the treatment of acute promyelocytic leukaemia (blood cancer) and Fampridine Accord (fampridine), intended to improve walking of adult patients suffering from multiple sclerosis with walking disability.

Negative recommendations on new medicines

The CHMP adopted negative opinions recommending the refusal of marketing authorisations for Elzonris (tagraxofusp) and Gamifant (emapalumab).

Elzonris was expected to be used for the treatment of blastic plasmacytoid dendritic cell neoplasm, a rare and aggressive type of acute myeloid leukaemia (blood cancer). Gamifant was expected to be used to treat primary haemophagocytic lymphohistiocytosis (a genetic disease characterised by an overactive immune system) in children under 18 years of age.

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

Nine recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Crysvita, HyQvia, Imbruvica, Imfinzi, Kalydeco, Latuda, NovoThirteen, Prezista and Shingrix.

Change to non-prescription status

The CHMP recommended a change in classification status from prescription to non-prescription for Fortacin (lidocaine / prilocaine), a medicine to treat men with primary (lifelong) premature ejaculation. For more information, see the summary of opinion document in the grid below.

Outcome of review on medicines tested by Panexcell Clinical Laboratories

The Committee recommended the suspension of the marketing authorisations of generic medicines tested by Panexcell Clinical Laboratories Priv. Ltd at its site in Mumbai, India. The recommendation comes after Austrian and German inspectors found irregularities in how the company carried out bioequivalence studies, which are used to show that a generic medicine produces the same amount of active substance in the body as the reference medicine.

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

Outcome of review on Yondelis

The CHMP recommended that the use of Yondelis (trabectedin) in treating ovarian cancer remains unchanged following a review of a study that investigated Yondelis as a third line treatment in patients with ovarian cancer. However, the study results will be included in the medicine’s product information to provide healthcare professionals with the most up-to-date information.

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

Start of referral

The Committee started a review of the results from the RECOVERY study arm that involved the use of dexamethasone in the treatment of patients with COVID-19 admitted to hospital. The review aims to provide an opinion on the results of the study and in particular the potential use of dexamethasone for the treatment of adults with COVID-19. For more information, see the start-of-referral document in the grid below.

Withdrawals of applications

Applications for initial marketing authorisations for Rayoqta (abicipar pegol) and Abilify MyCite (aripiprazole) have been withdrawn.

Rayoqta was expected to be used to treat age-related macular degeneration, a disease which affects the central part of the retina (called the macula) at the back of the eye and causes gradual loss of vision. Abilify MyCite was expected to be used to treat schizophrenia and bipolar I disorder.

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

Agenda and minutes

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

CHMP statistics

Key figures from the July 2020 CHMP meeting are represented in the graphic below.

* These products were designated as an orphan medicines during their 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 medicines' orphan status and granting the medicines ten years of market exclusivity.

CHMP statistics: July 2020

Positive recommendations on new medicines

Name of medicineAdakveo
INNcrizanlizumab
Marketing-authorisation applicantNovartis Europharm Limited
Therapeutic indicationPrevention of recurrent vaso-occlusive crises in patients with sickle cell disease
More informationAdakveo: Pending EC decision

 

Name of medicineArikayce liposomal
INNamikacin
Marketing-authorisation applicantInsmed Netherlands B.V.
Therapeutic indicationTreatment of non-tuberculous mycobacterial lung infections caused by Mycobacterium avium Complex in adults with limited treatment options who do not have cystic fibrosis
More informationArikayce liposomal: Pending EC decision

 

Name of medicineAyvakyt
INNavapritinib
Marketing-authorisation applicantBlueprint Medicines (Netherlands) B.V.
Therapeutic indicationTreatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours harbouring the platelet-derived growth factor receptor alpha D842V mutation
More information

Ayvakyt: Pending EC decision

 

Name of medicineBlenrep
INNbelantamab mafodotin 
Marketing-authorisation applicantGlaxoSmithKline (Ireland) Limited
Therapeutic indicationTreatment of relapsed and refractory multiple myeloma
More information

Blenrep: Pending EC decision


News: First antibody-drug conjugate for multiple myeloma patients with limited treatment options

 

Name of medicineCalquence
INNacalabrutinib
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationTreatment of chronic lymphocytic leukaemia
More informationCalquence: Pending EC decision

 

Name of medicineJyseleca
INNfilgotinib
Marketing-authorisation applicantGilead Sciences Ireland UC
Therapeutic indicationTreatment of rheumatoid arthritis
More information

Jyseleca: Pending EC decision

 

Name of medicineZynrelef
INNbupivacaine / meloxicam
Marketing-authorisation applicantHeron Therapeutics, B.V.
Therapeutic indicationTreatment of post-operative pain
More information

Zynrelef: Pending EC decision

 

Positive recommendation on new biosimilar medicine

Name of medicineEquidacent
INNbevacizumab 
Marketing-authorisation applicantCentus Biotherapeutics Europe Limited
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 informationEquidacent: Pending EC decision

 

Positive recommendations on new generic medicines

Name of medicineArsenic trioxide medac 
INNarsenic trioxide 
Marketing-authorisation applicantmedac Gesellschaft fur klinische Spezialpraparate mbH
Therapeutic indicationTreatment of acute promyelocytic leukaemia
More informationArsenic trioxide medac: Pending EC decision

 

Name of medicineFampridine Accord 
INNfampridine
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationImprovement of walking in adult patients with multiple sclerosis with walking disability
More informationFampridine Accord: Pending EC decision

 

Positive recommendation on medicine for use outside the European Union

Name of medicineDapivirine Vaginal Ring 25 mg 
INNdapivirine
Marketing-authorisation applicantInternational Partnership for Microbicides Belgium AISBL
Therapeutic indicationProphylaxis against HIV-1 infection via vaginal intercourse in HIV-uninfected women 18 years and older in combination with safer sex practices when oral pre-exposure prophylaxis is not/cannot be used or is not available
More information

CHMP summary of opinion for Dapivirine Vaginal Ring 25 mg


News: Vaginal ring to reduce the risk of HIV infection for women in non-EU countries with high disease burden

 

Negative recommendation on new medicine

Name of medicineElzonris
INNtagraxofusp
Marketing-authorisation applicantStemline Therapeutics B.V.
Therapeutic indicationTreatment of blastic plasmacytoid dendritic cell neoplasm
More informationElzonris: Questions and answers

 

Name of medicineGamifant
INNemapalumab
Marketing-authorisation applicantSwedish Orphan Biovitrum AB (publ)
Therapeutic indicationTreatment of primary haemophagocytic lymphohistiocytosis in children under 18 years of age
More informationGamifant: Questions and answers

 

Positive recommendations on extensions of indications

Name of medicineCrysvita
INNburosumab
Marketing-authorisation holderKyowa Kirin Holdings B.V.
More informationCrysvita: Pending EC decision

 

Name of medicineHyQvia
INNhuman normal immunoglobulin 
Marketing-authorisation holderBaxalta Innovations GmbH
More informationHyQvia: Pending Ec decision

 

Name of medicineImbruvica
INNibrutinib
Marketing-authorisation holderJanssen-Cilag International NV
More informationImbruvica: Pending EC decision

 

Name of medicineImfinzi
INNdurvalumab
Marketing-authorisation holderAstraZeneca AB
More informationImfinzi: Pending EC decision

 

Name of medicineKalydeco
INNivacaftor
Marketing-authorisation holderVertex Pharmaceuticals (Ireland) Limited
More informationKalydeco: Pending EC decision

 

Name of medicineLatuda
INNlurasidone
Marketing-authorisation holderAziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
More informationLatuda: Pending EC decision

 

Name of medicineNovoThirteen
INNcatridecacog
Marketing-authorisation holderNovo Nordisk A/S
More informationNovoThirteen: Pending EC decision

 

Name of medicinePrezista
INNdarunavir
Marketing-authorisation holderJanssen-Cilag International NV
More informationPrezista: Pending EC decision

 

Name of medicineShingrix
Common nameherpes zoster vaccine (recombinant, adjuvanted)
Marketing-authorisation holderGlaxoSmithkline Biologicals SA
More informationShingrix: Pending EC decision

 

Recommendation for new contraindication

Name of medicineReyataz
INNatazanavir sulphate
Marketing-authorisation applicantBristol-Myers Squibb Pharma EEIG
More informationReyataz: Pending EC decision

 

Other opinions

Name of medicineFortacin
INNlidocaine / prilocaine
Marketing-authorisation applicantRecordati Ireland Ltd
More informationFortacin: Pending EC decision

 

Name of medicineVotubia
INNeverolimus
Marketing-authorisation applicantNovartis Europharm Limited
More information PDF iconQuestions and answers on the use of Votubia in children from 6 months of age

 

Public-health recommendations

Name of medicinePanexcell
More informationPanexcell Article-31 referralPanexcell Clinical Laboratories: suspension of medicines over flawed studies

 

Name of medicineYondelis
INNPharma Mar S.A.
More informationYondelis Article-20 procedure: Authorised uses of cancer medicine Yondelis unchanged following review of new data

 

Outcome of arbitration procedure

Name of medicineIbuprofen Kabi 400 mg Infusionslösung and associated names
Marketing-authorisation holderFresenius Kabi Deutschland GmbH
More informationIbuprofen Kabi 400 mg Infusionslösung and associated names Article 29(4) referralEMA recommends authorisation of Ibuprofen Kabi (ibuprofen, 400 mg solution for infusion) in the EU

 

Opinions on any scientific matter (Article 5(3))

Withdrawals of initial marketing authorisation applications

Name of medicineRayoqta
INNabicipar pegol 
Marketing-authorisation applicantAllergan Pharmaceuticals International Limited
More informationRayoqta: Withdrawn application

 

Name of medicineAbilify MyCite
INNaripiprazole
Marketing-authorisation applicantOtsuka Pharmaceutical Netherlands B.V.
More informationAbilify Mycite: Withdrawn application

 

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