Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 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The application for an initial marketing authorisation for Prohippur (sodium benzoate) was withdrawn.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An application to extend the use of Qtern (saxagliptin / dapagliflozin) in patients with type 2 diabetes has also been withdrawn.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.

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Positive recommendations on new medicines

Name of medicine	Biktarvy
International non-proprietary name (INN)	bictegravir / emtricitabine / tenofovir alafenamide
Marketing-authorisation applicant	Gilead Sciences International Limited
Therapeutic indication	Treatment of HIV-1 infection
More information	Summary of opinion for Biktarvy

Name of medicine	Dzuveo
INN	sufentanil
Marketing-authorisation applicant	FGK Representative Service GmbH
Therapeutic indication	Treatment of pain
More information	Summary of opinion for Dzuveo

Positive recommendation on new generic medicine

Name of medicine	Carmustine Obvius
INN	carmustine
Marketing-authorisation applicant	Obvius Investment BV
Therapeutic indication	Treatment of brain tumours, non-Hodgkin's lymphoma and Hodgkin's disease
More information	Summary of opinion for Carmustine Obvius

Start of re-examination of recommendation for new medicines

Name of medicine	Dexxience
INN	betrixaban
Marketing-authorisation applicant	Portola Pharma UK Limited
Therapeutic indication	Prevention of venous thromboembolism
More information	Questions and answers on Dexxience

Name of medicine	Eladynos
INN	abaloparatide
Marketing-authorisation applicant	Radius International Ltd
Therapeutic indication	Treatment of osteoporosis
More information	Questions and answers on Eladynos

Positive recommendations on extensions of indications

Name of medicine	Cimzia
INN	certolizumab pegol
Marketing-authorisation holder	UCB Pharma SA
More information	Summary of opinion for Cimzia

Name of medicine	Perjeta
INN	pertuzumab
Marketing-authorisation holder	Roche Registration GmbH
More information	Summary of opinion for Perjeta

Name of medicine	Prolia
INN	denosumab
Marketing-authorisation holder	Amgen Europe B.V.
More information	Summary of opinion for Prolia

Name of medicine	Tagrisso
INN	osimertinib
Marketing-authorisation holder	AstraZeneca AB
More information	Summary of opinion for Tagrisso

Name of medicine	Xeljanz
INN	tofacitinib
Marketing-authorisation holder	Pfizer Limited
More information	Summary of opinion for Xeljanz

Name of medicine	Xultophy
INN	insulin degludec / liraglutide
Marketing-authorisation holder	Novo Nordisk A/S
More information	Summary of opinion for Xultophy

Name of medicine	Yervoy
INN	ipilimumab
Marketing-authorisation holder	Bristol-Myers Squibb Pharma EEIG
More information	Summary of opinion for Yervoy

Withdrawal of initial marketing authorisation application

Name of medicine	Prohippur
INN	sodium benzoate
Marketing-authorisation applicant	Lucane Pharma
More information	Questions and answers on Prohippur

Withdrawal of extension of indication application

Name of medicine	Qtern
INN	saxagliptin / dapagliflozin
Marketing-authorisation holder	Astra Zeneca AB
More information	Questions and answers on Qtern

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