Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020

News 29/05/2020

Eight new medicines recommended for approval

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

The Committee recommended granting a marketing authorisation for a new vaccine that provides active immunisation to prevent Ebola virus disease in individuals aged one year and older. The new Ebola vaccine consists of two components, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). Zabdeno is given first and Mvabea is administered approximately eight weeks later as a booster. Zabdeno and Mvabea were evaluated under EMA's accelerated assessment mechanism, a tool which aims to speed up patients' access to new medicines if there is an unmet medical need. For more information, see the press release in the grid below.

The CHMP recommended granting a marketing authorisation for Hepcludex* (bulevirtide), for the treatment of chronic hepatitis delta virus infection in adult patients with compensated liver disease. Because there are no treatments currently approved for hepatitis D, Hepcludex 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.

Piqray (alpelisib) received a positive opinion from the CHMP for the treatment of locally advanced or metastatic breast cancer with a PIK3CA mutation.

The CHMP recommended granting a conditional marketing authorisation for Rozlytrek (entrectinib), for the treatment of patients whose solid tumours have a neurotrophic tyrosine receptor kinase gene fusion, or patients with ROS1-positive advanced non-small cell lung cancer.

Xenleta (lefamulin) received a positive opinion for the treatment of community-acquired pneumonia in adults.

The biosimilar medicine Zercepac (trastuzumab) received a positive opinion for the treatment of breast and gastric cancer.

The generic medicine Apixaban Accord (apixaban) received a positive opinion for the treatment and prevention of venous thromboembolic events in adult patients and for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.

Five recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Invokana, Lynparza, Ofev, Sivextro and Taltz.

Update on remdesivir

The CHMP discussed the status of the review of remdesivir for treating patients with COVID-19. On 30 April 2020, the CHMP started a rolling review of data and the first cycle of this rolling review was concluded on 15 May; the CHMP requested some further data and agreed that the next step would be for the company to submit this data together with an application for a conditional marketing authorisation. The company has not yet submitted an application but it is expected to do so shortly. Once an application has been submitted, the Committee will assess it under a timeline which will be reduced to the absolute minimum to still allow for a thorough evaluation of benefits and risks, meaning an opinion could come soon depending on the robustness of the data submitted.

Withdrawals of applications

Applications for initial marketing authorisations for Erlotinib Accord (erlotinib) and Fingolimod Mylan (fingolimod) have been withdrawn. Erlotinib Accord was intended for the treatment of non-small-cell lung cancer and pancreatic cancer. Fingolimod Mylan was intended for the treatment of multiple sclerosis.

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

Agenda and minutes

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

CHMP statistics

Key figures from the May 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 highlights May 2020

Positive recommendations on new medicines

Name of medicineHepcludex
INNbulevirtide
Marketing-authorisation applicantMYR GmbH
Therapeutic indicationTreatment of chronic hepatitis delta virus infection in adult patients with compensated liver disease
More informationHepcludex: Pending EC decision

 

Name of medicineMvabea
Common nameEbola vaccine (MVA-BN-Filo [recombinant])
Marketing-authorisation applicantJanssen-Cilag International N.V.
Therapeutic indicationProphylaxis against Zaire ebolavirus disease
More information

Mvabea: Pending EC decision

Press release:New vaccine for prevention of Ebola virus disease recommended for approval in the European Union

 

Name of medicinePiqray
INNalpelisib
Marketing-authorisation applicantNovartis Europharm Limited
Therapeutic indicationTreatment of locally advanced or metastatic breast cancer with a PIK3CA mutation
More informationPiqray: Pending EC decision

 

Name of medicineRozlytrek
INNentrectinib
Marketing-authorisation applicantRoche Registration GmbH
Therapeutic indicationTreatment of patients whose solid tumours have a neurotrophic tyrosine receptor kinase gene fusion, or patients with ROS1-positive advanced non-small cell lung cancer
More informationRozlytrek: Pending EC decision

 

Name of medicineXenleta
INNlefamulin
Marketing-authorisation applicantNabriva Therapeutics Ireland DAC
Therapeutic indicationTreatment of community-acquired pneumonia in adults
More informationXenleta: Pending EC decision

 

Name of medicineZabdeno
Common nameEbola vaccine (Ad26.ZEBOV-GP [recombinant])
Marketing-authorisation applicantJanssen-Cilag International N.V.
Therapeutic indicationProphylaxis against Zaire ebolavirus disease
More information

Zabdeno: Pending EC decision

Press release:New vaccine for prevention of Ebola virus disease recommended for approval in the European Union

 

Positive recommendation on new biosimilar medicine

Name of medicineZercepac
INNtrastuzumab
Marketing-authorisation holderAccord Healthcare S.L.U.
Therapeutic indicationTreatment of breast and gastric cancer
More informationZercepac: Pending EC decision

 

Positive recommendation new generic medicine

Name of medicineApixaban Accord
INNapixaban
Marketing-authorisation holderAccord Healthcare S.L.U.
Therapeutic indicationTreatment and prevention of venous thromboembolic events in adult patients and for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation
More informationApixaban Accord: Pending EC decision

 

Positive recommendations on extensions of indications

Name of medicineInvokana
INNcanagliflozin
Marketing-authorisation holderJanssen-Cilag International NV
More informationInvokana: Pending EC decision

 

Name of medicineLynparza
INNolaparib
Marketing-authorisation holderAstraZeneca AB
More informationLynparza: Pending EC decision

 

Name of medicineOfev
INNnintedanib
Marketing-authorisation holderBoehringer Ingelheim International GmbH
More informationOfev: Pending EC decision

 

Name of medicineSivextro
INNtedizolid phosphate
Marketing-authorisation holderMerck Sharp & Dohme B.V.
More informationSivextro: Pending EC decision

 

Name of medicineTaltz
INNixekizumab
Marketing-authorisation holderEli Lilly Nederland B.V.
More informationTaltz: Pending EC decision

 

Withdrawals of initial marketing authorisation applications

Name of medicineErlotinib Accord
INNerlotinib
Marketing-authorisation applicantAccord Healthcare S.L.U.
More informationErlotinib Accord: Withdrawn application

 

Name of medicineFingolimod Mylan
INNfingolimod
Marketing-authorisation applicantMylan Ireland Limited
More informationFingolimod Mylan: Withdrawn application

 

Other opinions

Name of medicineTrumenba
Common namemeningococcal group B vaccine (recombinant, adsorbed)
Marketing-authorisation holderPfizer Europe MA EEIG
More information PDF iconQuestions and answers on the use of Trumenba in children between 1 and 9 years of age

 

Name of medicineVokanamet
Common namecanagliflozin / metformin
Marketing-authorisation holderJanssen-Cilag International N.V.
More information PDF iconQuestions and answers on the use of Vokanamet in diabetic kidney disease

 

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