Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2018

News 27/04/2018

Three medicines recommended for approval

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended three medicines for approval at its April 2018 meeting.

The CHMP recommended granting a marketing authorisation for Biktarvy (bictegravir / emtricitabine / tenofovir alafenamide), for the treatment of HIV-1 infection.

One hybrid medicine, Dzuveo (sufentanil) received a positive opinion for the treatment of pain. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.

The Committee recommended for approval the generic medicine Carmustine Obvius (carmustine), for the treatment brain tumours, non-Hodgkin's lymphoma and Hodgkin's disease.

Start of re-examination of recommendations on new medicines

The applicants for Dexxience (betrixaban) and Eladynos (abaloparatide) have requested re-examinations of the CHMP's negative opinions for these medicines adopted at the March 2018 meeting.

The applicant for Alsitek (masitinib) has also requested a re-examination of the Committee's negative opinion for this medicine, which was adopted via written procedure on 18 April 2018.

The CHMP will now re-examine these opinions and issue final recommendations. For more information on the negative opinions, please see the question-and-answer documents in the grid below.

Eight recommendations on extensions of therapeutic indication

The Committee recommended extensions of indications for Cimzia, Perjeta, Prolia, Sprycel, Tagrisso, Xeljanz, Xultophy and Yervoy.

Withdrawals of applications

The application for an initial marketing authorisation for Prohippur (sodium benzoate) was withdrawn. This medicine was intended to be used for the treatment of non-ketotic hyperglycinaemia and urea cycle disorders.

An application to extend the use of Qtern (saxagliptin / dapagliflozin) in patients with type 2 diabetes has also been withdrawn.

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

Agenda and minutes

The agenda of the April 2018 meeting is published on EMA's website. Minutes of the March 2018 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the April 2018 CHMP meeting are represented in the graphic below.

More information on all other outcomes of the CHMP April 2018 meeting is available in the grid below.

 April 2018 infographic

Download image in PDF format

Positive recommendations on new medicines

Name of medicineBiktarvy
International non-proprietary name (INN)bictegravir / emtricitabine / tenofovir alafenamide
Marketing-authorisation applicantGilead Sciences International Limited
Therapeutic indicationTreatment of HIV-1 infection
More information PDF iconSummary of opinion for Biktarvy

Name of medicineDzuveo
INNsufentanil
Marketing-authorisation applicantFGK Representative Service GmbH
Therapeutic indicationTreatment of pain
More information PDF iconSummary of opinion for Dzuveo

Positive recommendation on new generic medicine

Name of medicineCarmustine Obvius
INNcarmustine
Marketing-authorisation applicantObvius Investment BV
Therapeutic indicationTreatment of brain tumours, non-Hodgkin's lymphoma and Hodgkin's disease
More information PDF iconSummary of opinion for Carmustine Obvius

Start of re-examination of recommendation for new medicines

Name of medicineAlsitek*
INNmasitinib
Marketing-authorisation applicantAB Science
Therapeutic indicationTreatment of amyotrophic lateral sclerosis
More information

PDF iconQuestions and answers on Alsitek

* The CHMP adopted a negative opinion for this medicine via written procedure on 18 April 2018

Name of medicineDexxience
INNbetrixaban
Marketing-authorisation applicantPortola Pharma UK Limited
Therapeutic indicationPrevention of venous thromboembolism
More information PDF iconQuestions and answers on Dexxience

Name of medicineEladynos
INNabaloparatide
Marketing-authorisation applicantRadius International Ltd
Therapeutic indicationTreatment of osteoporosis
More information PDF iconQuestions and answers on Eladynos

Positive recommendations on extensions of indications

Name of medicineCimzia
INNcertolizumab pegol
Marketing-authorisation holderUCB Pharma SA
More information PDF iconSummary of opinion for Cimzia

Name of medicinePerjeta
INNpertuzumab
Marketing-authorisation holderRoche Registration GmbH
More information PDF iconSummary of opinion for Perjeta

Name of medicineProlia
INNdenosumab
Marketing-authorisation holderAmgen Europe B.V.
More information PDF iconSummary of opinion for Prolia

Name of medicineSprycel
INNdasatinib
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More informationSummary of opinion for Sprycel

Name of medicineTagrisso
INNosimertinib
Marketing-authorisation holderAstraZeneca AB
More information PDF iconSummary of opinion for Tagrisso

Name of medicineXeljanz
INNtofacitinib
Marketing-authorisation holderPfizer Limited
More information PDF iconSummary of opinion for Xeljanz

Name of medicineXultophy
INNinsulin degludec / liraglutide
Marketing-authorisation holderNovo Nordisk A/S
More information PDF iconSummary of opinion for Xultophy

Name of medicineYervoy
INNipilimumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More information PDF iconSummary of opinion for Yervoy

Withdrawal of initial marketing authorisation application

Name of medicineProhippur
INNsodium benzoate
Marketing-authorisation applicantLucane Pharma
More information PDF iconQuestions and answers on Prohippur

Withdrawal of extension of indication application

Name of medicineQtern
INNsaxagliptin / dapagliflozin
Marketing-authorisation holderAstra Zeneca AB
More information PDF iconQuestions and answers on Qtern

Other updates

Recommendations on eligibility to PRIME scheme
PDF iconStart of community reviews
PDF iconScientific advice and protocol assistance

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