Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 2016

26 February 2016

Six medicines, including two orphan medicines, recommended for approval

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines for marketing authorisation at its February 2016 meeting.

The CHMP recommended granting marketing authorisations for two medicines for the prevention and treatment of bleeding in patients with haemophilia B, Alprolix (eftrenonacog alfa) and Idelvion (albutrepenonacog alfa). Both these medicines have an orphan designation.

Lonsurf (trifluridine / tipiracil) was recommended by the CHMP for the treatment of metastatic colorectal cancer.

Descovy (emtricitabine / tenofovir alafenamide) received a positive opinion for the treatment of HIV infection.

The CHMP recommended granting a marketing authorisation for Taltz (ixekizumab) for the treatment of plaque psoriasis.

The generic medicine Palonosetron Hospira (palonosetron) received a positive recommendation from the Committee for the prevention of nausea and vomiting associated with chemotherapy.

Seven recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Giotrif, Humira, Ruconest, TachoSil, Zydelig and two extensions of indications for Opdivo. For more information on the extensions of indications for Opdivo, please see the press release in the grid below.

Start of review: medicines containing dienogest and ethinylestradiol

The CHMP started a review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg when used for acne. These products are available in several countries in the European Union (EU) as oral contraceptives and for the treatment of moderate acne in women. For more information, please refer to the start of referral document in the grid below.

Outcome of review on SGLT2 inhibitors: recommendations to minimise risk of diabetic ketoacidosis

The CHMP confirmed recommendations from the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risk of diabetic ketoacidosis in patients taking SGLT2 inhibitors (a class of type 2 diabetes medicines). For more information, please see the public health communication in the grid below.

CHMP confirms recommendations to minimise risk of the brain infection PML with Tysabri

EMA's scientific review of the known risk of progressive multifocal leukoencephalopathy (PML) with the multiple sclerosis medicine Tysabri (natalizumab) is now completed, with the CHMP confirming the PRAC recommendations aimed at minimising this risk. For more information, please see the public health communication in the grid below.

PRIME and early access tools

The CHMP adopted the final document on PRIME, a new scheme to support the development of medicines addressing unmet medical needs, as well as revised guidelines on the implementation of accelerated assessment and conditional marketing authorisation. These documents will be published on the EMA website in early March.

Agenda and minutes

The agenda of the February 2016 meeting is published on EMA's website. Minutes of the January 2016 CHMP meeting will be published next week.

CHMP statistics

Key figures from the February 2016 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP's February 2016 meeting, is available in the grid below.

CHMP statistics: February 2016

 

Positive recommendations on new medicines

Name of medicine	Alprolix
INN	eftrenonacog alfa
Marketing-authorisation applicant	Biogen Idec Ltd
Therapeutic indication	Treatment and prophylaxis of bleeding in patients with haemophilia B
More information	CHMP summary of opinion for Alprolix

 

Name of medicine	Descovy
INN	emtricitabine / tenofovir alafenamide
Marketing-authorisation applicant	Gilead Sciences International Ltd
Therapeutic indication	Treatment of HIV infection
More information	CHMP summary of positive opinion for Descovy

 

Name of medicine	Idelvion
INN	albutrepenonacog alfa
Marketing-authorisation applicant	CSL Behring GmbH
Therapeutic indication	Treatment and prophylaxis of bleeding in patients with haemophilia B
More information	CHMP summary of positive opinion for Idelvion

 

Name of medicine	Lonsurf
INN	trifluridine / tipiracil
Marketing-authorisation applicant	Les Laboratoires Servier
Therapeutic indication	Treatment of metastatic colorectal cancer
More information	CHMP summary of positive opinion for Lonsurf

 

Name of medicine	Taltz
INN	ixekizumab
Marketing-authorisation applicant	Eli Lilly Nederland B.V.
Therapeutic indication	Treatment of plaque psoriasis
More information	CHMP summary of positive opinion for Taltz

 

Positive recommendation on new generic medicine

Name of medicine	Palonosetron Hospira
INN	palonosetron
Marketing-authorisation applicant	Hospira UK Limited
Therapeutic indication	Prevention of nausea and vomiting associated with cancer chemotherapy
More information	CHMP summary of opinion for Palonosetron Hospira

 

Positive recommendations on extensions of therapeutic indications

Name of medicine	Giotrif
INN	afatinib
Marketing-authorisation holder	Boehringer Ingelheim International GmbH
More information	CHMP post-authorisation summary of positive opinion for Giotrif

 

Name of medicine	Humira
INN	adalimumab
Marketing-authorisation holder	AbbVie Ltd
More information	CHMP post-authorisation summary of positive opinion for Humira

 

Name of medicine	Opdivo
INN	nivolumab
Marketing-authorisation holder	Bristol-Myers Squibb Pharma EEIG
More information	CHMP post-authorisation summary of positive opinion for Opdivo (II/0002)   Press release: New treatment for advanced form of kidney cancer

 

Name of medicine	Ruconest
INN	conestat alfa
Marketing-authorisation holder	Pharming Group N.V
More information	CHMP post-authorisation summary of positive opinion for Ruconest

 

Name of medicine	TachoSil
INN	human thrombin / human fibrinogen
Marketing-authorisation holder	Takeda Austria GmbH
More information	CHMP post-authorisation summary of positive opinion for TachoSil

 

Name of medicine	Zydelig
INN	idelalisib
Marketing-authorisation holder	Gilead Sciences International Ltd
More information	CHMP post-authorisation summary of positive opinion for Zydelig

 

Recommendation for new contraindication

Name of medicine	Telzir
INN	fosamprenavir
Marketing-authorisation holder	ViiV Healthcare UK Limited
More information	CHMP post-authorisation summary of positive opinion for Telzir

 

Start of referral

Name of medicine	Dienogest / Ethinylestradiol containing medicinal products indicated in acne
INN	dienogest / ethinylestradiol
More information	Start of review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg for acne

 

Public health recommendations

Name of medicine	Tysabri
INN	natalizumab
Marketing-authorisation holder	Biogen Idec Ltd
More information	EMA confirms recommendations to minimise risk of brain infection PML with Tysabri

 

Name of medicine	SGLT2 inhibitors
INN	canagliflozin, dapagliflozin, empagliflozin
Marketing-authorisation holder	AstraZeneca AB (Forxiga, Xigduo), Boehringer Ingelheim International GmbH (Jardiance, Synjardy), Janssen-Cilag International N.V. (Invokana, Vokanamet)
More information	EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes

 

Outcome of harmonisation procedure

Name of medicine	Cymevene
INN	ganciclovir
Marketing-authorisation holder	F. Hoffmann-La Roche
More information	Questions and answers on Cymevene and associated names (ganciclovir, 500 mg powder for concentrate for solution for infusion, intravenous

 

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 22-25 February 2016

Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 22-25 February 2016

Start of community reviews - CHMP meeting of 22-25 February 2016

Scientific advice and protocol assistance adopted during the CHMP meeting 22-25 February 2016

Guidelines and concept papers adopted during the CHMP meeting 22-25 February 2016

Overview of (invented) names reviewed in February 2016 by the Name Review Group (NRG) adopted at the CHMP meeting of 22-25 February 2016

Organisational matters - CHMP meeting 22-25 February 2016