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

News 22/07/2016

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.

CHMP highlights July 2016

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Positive recommendations on new medicines

Name of medicineCabometyx
International non-proprietary name (INN)cabozantinib
Marketing-authorisation applicantIpsen Pharma
Therapeutic indicationTreatment of advanced renal cell carcinoma
More information

PDF iconSummary of opinion for Cabometyx

Press release: Two new medicines for advanced kidney cancer

Name of medicineOnivyde
INNirinotecan
Marketing-authorisation applicantBaxter Innovations GmbH
Therapeutic indicationTreatment of metastatic adenocarcinoma of the pancreas
More information PDF iconSummary of opinion for Onivyde

Name of medicineKisplyx
INNlenvatinib
Marketing-authorisation applicantEisai Europe Ltd
Therapeutic indicationIn combination with everolimus for the treatment of unresectable advanced or metastatic renal cell carcinoma
More information

PDF iconSummary of opinion for Kisplyx

Press release: Two new medicines for advanced kidney cancer

Name of medicineSialanar
INNglycopyrronium bromide
Marketing-authorisation applicantProveca Limited
Therapeutic indicationSymptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders
More information

PDF iconSummary of opinion for Sialanar

PDF iconQuestions and answers on Sialanar

Name of medicineTruberzi
INNeluxadoline
Marketing-authorisation applicantAptalis Pharma SAS
Therapeutic indicationTreatment of irritable bowel syndrome with diarrhoea
More information PDF iconSummary of opinion for Truberzi

Positive recommendation on new generic medicine

Name of medicineTenofovir disoproxil Zentiva
INNtenofovir disoproxil
Marketing-authorisation applicantZentiva k.s
Therapeutic indicationTreatment of HIV-1 infection and hepatitis B infection
More information PDF iconSummary of opinion for Tenofovir disoproxil Zentiva

Positive recommendations on new biosimilar medicines

Name of medicineInhixa
International non-proprietary name (INN)enoxaparin sodium
Marketing-authorisation applicantTechdow Europe AB
Therapeutic indicationPrevention and treatment of various disorders related to blood clots in adults
More information PDF iconSummary of opinion for Inhixa

Name of medicineThorinane
International non-proprietary name (INN)enoxaparin sodium
Marketing-authorisation applicantPharmathen S.A.
Therapeutic indicationPrevention and treatment of various disorders related to blood clots in adults
More information PDF iconSummary of opinion for Thorinane

Positive recommendations on extensions of therapeutic indications

Name of medicineAmeluz
INN5-aminolevulinic acid
Marketing-authorisation holderBiofrontera Bioscience GmbH
More information PDF iconSummary of opinion for Ameluz

Name of medicineImbruvica
INNibrutinib
Marketing-authorisation holderJanssen-Cilag International NV
More information PDF iconSummary of opinion for Imbruvica

Name of medicineOrencia
INNabatacept
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More information PDF iconSummary of opinion for Orencia

Name of medicineTruvada
INNemtricitabine / tenofovir disoproxil
Marketing-authorisation holderGilead Sciences International Ltd
More information

PDF iconSummary of opinion for Truvada

Press release: First medicine for HIV pre-exposure prophylaxis recommended for approval in the EU

Name of medicineXalkori
INNcrizotinib
Marketing-authorisation holderPfizer Limited
More information PDF iconSummary of opinion for Xalkori

Public-health recommendation

Name of the procedureSemler
More informationEMA recommends suspension of medicines over flawed studies at Semler Research Centre

Name of medicineZydelig
INNidelalisib
Marketing-authorisation holderGilead Sciences International Ltd
More informationCHMP confirms recommendations for use of Zydelig

Outcome of arbitration procedure

Name of medicineDiclofenac epolamine 50mg tablets
INNdiclofenac epolamine
Marketing-authorisation holderAltergon Italia srl
More informationQuestions and answer on Diclofenac epolamine 50mg tablets

Outcome of harmonisation procedure

Name of medicineDurogesic and associated names
INNfentanyl
Marketing-authorisation holderJanssen-Cilag group and associated companies
More informationQuestions and answers on Durogesic and associated names (fentanyl transdermal patches)

Withdrawal of application

Name of medicineBegedina
INNbegelomab
More information PDF iconQuestions and answers on Begedina

Other updates

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconRecommendations on eligibility to PRIME scheme
PDF iconOpinions on safety variations
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
PDF iconOverview of invented names reviewed in July 2016 by the Name Review Group (NRG)
PDF iconOrganisational matters

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