Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2016

14 October 2016

Eight medicines recommended for approval, including four orphan medicines

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its October meeting.

The CHMP recommended granting a conditional marketing authorisation for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (also known as primary bile cirrhosis). Ocaliva is an orphan-designated medicine. For more information, please see the press release in the grid below.

The Committee recommended granting a conditional marketing authorisation for Venclyxto (venetoclax) for the treatment of adults with chronic lymphocytic leukaemia (CLL). Venclyxto has an orphan designation.

Cystadrops (mercaptamine) was recommended for approval by the CHMP for the treatment of corneal cystine crystal deposits in patients with cystinosis. Cystadrops has an orphan designation.

Rekovelle (follitropin delta) was recommended for approval for controlled ovarian stimulation.

The Committee recommended granting a marketing authorisation for the orphan medicine SomaKit-TOC (edotreotide) for the diagnosis of gastro-entero-pancreatic neuroendrocrine tumours.

Three generic medicines were recommended for approval: Emtricitabine / Tenofovir disoproxil Mylan (emtricitabine / tenofovir disoproxil), Emtricitabine / Tenofovir disoproxil Krka (emtricitabine / tenofovir disoproxil) and Tenofovir disoproxil Mylan (tenofovir disoproxil). These three medicines are intended for the treatment of HIV infection in adults.

Four recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Lucentis, Opdivo, Trisenox and Zebinix.

Outcome of review of metformin-containing medicines

The CHMP has concluded that metformin-containing medicines can now be used in patients with moderately reduced kidney function for the treatment of type 2 diabetes. The recommendations are the result of a review by the Committee following concerns that current scientific evidence does not justify a contraindication in patients with moderate reduction of kidney function. Please see the public health communication in the grid below for more information.

CHMP recommends measures to ensure safe use of Keppra oral solution

Several measures have been put in place to ensure that the correct dosing syringe is used to measure Keppra (levetiracetam) oral solution, and thus avoid medication errors. Keppra is a medicine used to treat epilepsy in adults and children. For more information, please see the public health communication in the grid below.

Withdrawals of applications

Applications for marketing authorisations for Ertapenem Hospira (ertapenem), Pemetrexed (as ditromethamine) Hospira (pemetrexed) and Zemfirza (cediranib) have been withdrawn. Questions-and-answers documents on these withdrawals are available in the grid below.

Election of vice-chair of CHMP

The CHMP has elected a new vice-chair, Dr Harald Enzmann, for a three-year mandate. Dr Enzmann, a medical doctor by training, is currently Head of European and International Affairs at the German Federal Institute for Drugs and Medical Devices (BfArM) in Bonn, Germany. He has been a member of the CHMP since 2005.

New CHMP documents to be made available

From October 2016, the annexes to the CHMP meeting agenda and minutes will be made public. These annexes include information on pre-submission issues, post-authorisation procedures, renewals of marketing authorisations and type II variations. These documents will be available on the CHMP: Agendas, minutes and highlights page.

From October 2016, EMA is also publishing the agendas and minutes of the CHMP Organisational Matters (ORGAM) meeting. ORGAM meetings take place one week before the CHMP meetings and cover topics arising from EMA working parties and drafting groups, such as scientific guidelines, as well as topics related to the organisation of the CHMP. The first ORGAM agenda was published last week and is available on the CHMP: Agendas, minutes and highlights page. The minutes will be published after the current month's CHMP plenary meeting on the same page.

From this month EMA will no longer publish the following annexes as part of the CHMP highlights: 'Opinions on safety variations', 'Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures', 'Guidelines and concept papers adopted' and 'Organisational matters'. This information will be included in the minutes of the CHMP meeting which are published approximately one month after the Committee meets.

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

CHMP statistics

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

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

CHMP statistics: October 2016

Positive recommendations on new medicines

Name of medicine	Cystadrops
International non-proprietary name (INN)	mercaptamine
Marketing-authorisation applicant	Orphan Europe S.A.R.L.
Therapeutic indication	Treatment of corneal cystine crystal deposits in patients with cystinosis
More information	CHMP summary of positive opinion for Cystadrops

 

Name of medicine	Ocaliva
INN	obeticholic acid
Marketing-authorisation applicant	Intercept Pharma Ltd
Therapeutic indication	Treatment of primary biliary cholangitis (also known as primary biliary cirrhosis)
More information	CHMP summary of positive opinion for Ocaliva   Press release: New medicine for rare, chronic liver disease

 

Name of medicine	Rekovelle
INN	follitropin delta
Marketing-authorisation applicant	Ferring Pharmaceuticals A/S
Therapeutic indication	Indicated for controlled ovarian stimulation
More information	CHMP summary of positive opinion for Rekovelle

 

Name of medicine	SomaKit-TOC
INN	edotreotide
Marketing-authorisation applicant	Advanced Accelerator Applications
Therapeutic indication	Diagnosis of gastro-entero-pancreatic neuroendocrine tumours
More information	CHMP summary of positive opinion for SomaKit TOC

 

Name of medicine	Venclyxto
INN	venetoclax
Marketing-authorisation applicant	AbbVie Ltd.
Therapeutic indication	Treatment of adult patients with chronic lymphocytic leukaemia
More information	CHMP summary of positive opinion for Venclyxto

 

Positive recommendations on new generic medicines

Name of medicine	Emtricitabine / Tenofovir disoproxil Mylan
INN	emtricitabine / tenofovir disoproxil
Marketing-authorisation applicant	MYLAN S.A.S.
Therapeutic indication	Treatment of HIV infection in adults
More information	CHMP summary of positive opinion for Emtricitabine/Tenofovir disoproxil Mylan

 

Name of medicine	Emtricitabine / Tenofovir Krka
INN	emtricitabine / tenofovir disoproxil
Marketing-authorisation applicant	KRKA, d.d., Novo mesto
Therapeutic indication	Treatment of HIV infection in adults
More information	CHMP summary of positive opinion for Emtricitabine/Tenofovir disoproxil Krka

 

Name of medicine	Tenofovir disoproxil Mylan
INN	tenofovir disoproxil
Marketing-authorisation applicant	MYLAN S.A.S.
Therapeutic indication	Treatment of HIV infection in adults
More information	CHMP summary of positive opinion for Tenofovir disoproxil Mylan

 

Positive recommendations on extensions of therapeutic indications

Name of medicine	Lucentis
INN	ranibizumab
Marketing-authorisation holder	Novartis Europharm Ltd
More information	CHMP post-authorisation summary of positive opinion for Lucentis

 

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

 

Name of medicine	Trisenox
INN	arsenic trioxide
Marketing-authorisation holder	Teva B.V.
More information	CHMP post-authorisation summary of positive opinion for Trisenox

 

Name of medicine	Zebinix
INN	eslicarbazepine acetate
Marketing-authorisation holder	BIAL - Portela & Ca, S.A.
More information	CHMP post-authorisation summary of positive opinion for Zebinix

 

Public-health recommendations

Name of the procedure	Metformin and metformin-containing medicines
More information	Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function

 

Name of the procedure	Keppra
INN	levetiracetam
Marketing-authorisation holder	UCB Pharma SA
More information	EMA recommends measures to ensure safe use of Keppra oral solution

 

Withdrawals of application

Name of medicine	Ertapenem Hospira
INN	ertapenem
More information	Questions and answers on the withdrawal of the marketing authorisation application for Ertapenem Hospira (ertapenem)

 

Name of medicine	Pemetrexed ditromethamine Hospira
INN	pemetrexed
More information	Questions and answers on the withdrawal of the marketing authorisation application for Pemetrexed ditromethamine Hospira

 

Name of medicine	Zemfirza
INN	cediranib
More information	Questions and answers on the withdrawal of the marketing authorisation application for Zemfirza (cediranib)

 

Other updates

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 October 2016

Scientific advice and protocol assistance adopted during the CHMP meeting 10 – 13 October 2016

Overview of invented names reviewed in September 2016 by the Name Review Group adopted at the CHMP meeting of 10-13 October 2016