Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2016

22 July 2016

Eight medicines recommended for approval; use of Truvada extended to include pre-exposure prophylaxis (PrEP) against HIV-1 infection

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

The CHMP recommended granting marketing authorisations for two medicines for the treatment of advanced renal cell carcinoma (kidney cancer). Cabometyx (cabozantinib) and Kisplyx (lenvatinib) are indicated for the treatment of adult patients with advanced renal cell carcinoma who have been previously treated with a vascular endothelial growth factor (VEGF) inhibitor; Cabometyx is to be used as monotherapy while Kisplyx is for use in combination with everolimus. For more information, please see the press release in the grid below.

The Committee recommended granting a paediatric use marketing authorisation (PUMA) for Sialanar (glycopyrronium bromide) to treat severe drooling in children and adolescents with neurological disorders. This followed a re-examination of the Committee's earlier negative opinion. PUMAs can be granted for medicines which are already authorised, but no longer under patent protection, and that have been developed specifically for children. This is the third time that the Committee has recommended a PUMA since the introduction of this type of marketing authorisation by the Paediatric Regulation, which came into force in 2007. Please see the questions and answers document in the grid below for more information on this opinion.

The Committee recommended granting a marketing authorisation for the orphan medicine Onivyde (irinotecan) for the treatment of metastatic adenocarcinoma of the pancreas.

Truberzi (eluxadoline) was recommended for approval for the treatment of irritable bowel syndrome with diarrhoea.

A generic medicine, Tenofovir disoproxil Zentiva (tenofovir disoproxil), was recommended for approval by the CHMP for the treatment of HIV-1 infection and chronic hepatitis B.

Two biosimilar medicines, Inhixa and Thorinane (both containing enoxaparin sodium), received positive opinions for the prevention and treatment of various disorders related to blood clots in adults.

Five recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Ameluz, Imbruvica, Orencia, Truvada and Xalkori.

A press release on the extension of indication for Truvada as pre-exposure prophylaxis (PrEP) against HIV-1 infection is available in the grid below.

CHMP confirms recommendations for use of Zydelig

The Committee confirmed that the benefits of Zydelig (idelalisib) in the treatment of the blood cancers chronic lymphocytic leukaemia (CLL) and follicular lymphoma outweigh the risk of side effects. However, following a review it has updated recommendations to minimise the risk of serious infections in patients treated with the medicine. For more information, please see the public health communication in the grid below.

CHMP recommends suspension of medicines over flawed studies at Semler Research Centre

The CHMP recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, Bangalore, India. For more information, please see the public health communication in the grid below.

Withdrawal of application

The application for a marketing authorisation for Begedina has been withdrawn. A questions and answers document on this withdrawal is available below.

Agenda and minutes

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

CHMP statistics

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

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

 

 

Positive recommendations on new medicines

Name of medicine	Cabometyx
International non-proprietary name (INN)	cabozantinib
Marketing-authorisation applicant	Ipsen Pharma
Therapeutic indication	Treatment of advanced renal cell carcinoma
More information	CHMP summary of positive opinion for Cabometyx   Press release: Two new medicines for advanced kidney cancer

 

Name of medicine	Onivyde
INN	irinotecan
Marketing-authorisation applicant	Baxter Innovations GmbH
Therapeutic indication	Treatment of metastatic adenocarcinoma of the pancreas
More information	CHMP summary of positive opinion for Onivyde

 

Name of medicine	Kisplyx
INN	lenvatinib
Marketing-authorisation applicant	Eisai Europe Ltd
Therapeutic indication	In combination with everolimus for the treatment of unresectable advanced or metastatic renal cell carcinoma
More information	CHMP summary of opinion for Kisplyx   Press release: Two new medicines for advanced kidney cancer

 

Name of medicine	Sialanar
INN	glycopyrronium bromide
Marketing-authorisation applicant	Proveca Limited
Therapeutic indication	Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders
More information	CHMP summary of opinion for Sialanar   Questions and answers on the positive opinion on the marketing authorisation for Sialanar (glycopyrronium bromide)

 

Name of medicine	Truberzi
INN	eluxadoline
Marketing-authorisation applicant	Aptalis Pharma SAS
Therapeutic indication	Treatment of irritable bowel syndrome with diarrhoea
More information

 

Positive recommendation on new generic medicine

Name of medicine	Tenofovir disoproxil Zentiva
INN	tenofovir disoproxil
Marketing-authorisation applicant	Zentiva k.s
Therapeutic indication	Treatment of HIV-1 infection and hepatitis B infection
More information	CHMP summary of opinion for Tenofovir disoproxil Zentiva

 

Positive recommendations on new biosimilar medicines

Name of medicine	Inhixa
International non-proprietary name (INN)	enoxaparin sodium
Marketing-authorisation applicant	Techdow Europe AB
Therapeutic indication	Prevention and treatment of various disorders related to blood clots in adults
More information	CHMP summary of positive opinion for Inhixa

 

Name of medicine	Thorinane
International non-proprietary name (INN)	enoxaparin sodium
Marketing-authorisation applicant	Pharmathen S.A.
Therapeutic indication	Prevention and treatment of various disorders related to blood clots in adults
More information

 

Positive recommendations on extensions of therapeutic indications

Name of medicine	Ameluz
INN	5-aminolevulinic acid
Marketing-authorisation holder	Biofrontera Bioscience GmbH
More information	CHMP post-authorisation summary of positive opinion for Ameluz

 

Name of medicine	Imbruvica
INN	ibrutinib
Marketing-authorisation holder	Janssen-Cilag International NV
More information	CHMP post-authorisation summary of positive opinion for Imbruvica

 

Name of medicine	Orencia
INN	abatacept
Marketing-authorisation holder	Bristol-Myers Squibb Pharma EEIG
More information	CHMP post-authorisation summary of positive opinion for Orencia

 

Name of medicine	Truvada
INN	emtricitabine / tenofovir disoproxil
Marketing-authorisation holder	Gilead Sciences International Ltd
More information	CHMP post-authorisation summary of positive opinion for Truvada   Press release: First medicine for HIV pre-exposure prophylaxis recommended for approval in the EU

 

Name of medicine	Xalkori
INN	crizotinib
Marketing-authorisation holder	Pfizer Limited
More information	CHMP post-authorisation summary of positive opinion for Xalkori

 

Public-health recommendation

Name of the procedure	Semler
More information	EMA recommends suspension of medicines over flawed studies at Semler Research Centre

 

Name of medicine	Zydelig
INN	idelalisib
Marketing-authorisation holder	Gilead Sciences International Ltd
More information	CHMP confirms recommendations for use of Zydelig

 

Outcome of arbitration procedure

Name of medicine	Diclofenac epolamine 50mg tablets
INN	diclofenac epolamine
Marketing-authorisation holder	Altergon Italia srl
More information	Questions and answer on Diclofenac epolamine 50mg tablets

 

Outcome of harmonisation procedure

Name of medicine	Durogesic and associated names
INN	fentanyl
Marketing-authorisation holder	Janssen-Cilag group and associated companies
More information	Questions and answers on Durogesic and associated names (fentanyl transdermal patches)

 

Withdrawal of application

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

 

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 18-21 July 2016

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 18-21 July 2016

Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 18-21 July 2016

Scientific advice and protocol assistance adopted during the CHMP meeting 18-21 July 2016

Guidelines and concept papers adopted during the CHMP meeting 18-21 July 2016

Overview of invented names reviewed in July 2016 by the Name Review Group (NRG) adopted at the CHMP meeting of 18-21 July 2016

Organisational matters: CHMP meeting 18-21 July 2016