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

News 14/10/2016

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.

 October 2016

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Positive recommendations on new medicines

Name of medicineCystadrops
International non-proprietary name (INN)mercaptamine
Marketing-authorisation applicantOrphan Europe S.A.R.L.
Therapeutic indicationTreatment of corneal cystine crystal deposits in patients with cystinosis
More information PDF iconSummary of opinion for Cystadrops

Name of medicineOcaliva
INNobeticholic acid
Marketing-authorisation applicantIntercept Pharma Ltd
Therapeutic indicationTreatment of primary biliary cholangitis (also known as primary biliary cirrhosis)
More information

PDF iconSummary of opinion for Ocaliva

Press release: New medicine for rare, chronic liver disease

Name of medicineRekovelle
INNfollitropin delta
Marketing-authorisation applicantFerring Pharmaceuticals A/S
Therapeutic indicationIndicated for controlled ovarian stimulation
More information PDF iconSummary of opinion for Rekovelle

Name of medicineSomaKit-TOC
INNedotreotide
Marketing-authorisation applicantAdvanced Accelerator Applications
Therapeutic indicationDiagnosis of gastro-entero-pancreatic neuroendocrine tumours
More information PDF iconSummary of opinion for SomaKit-TOC

Name of medicineVenclyxto
INNvenetoclax
Marketing-authorisation applicantAbbVie Ltd.
Therapeutic indicationTreatment of adult patients with chronic lymphocytic leukaemia
More information PDF iconSummary of opinion for Venclyxto

Positive recommendations on new generic medicines

Name of medicineEmtricitabine / Tenofovir disoproxil Mylan
INNemtricitabine / tenofovir disoproxil
Marketing-authorisation applicantMYLAN S.A.S.
Therapeutic indicationTreatment of HIV infection in adults
More information PDF iconSummary of opinion for Emtricitabine / Tenofovir disoproxil Mylan

Name of medicineEmtricitabine / Tenofovir Krka
INNemtricitabine / tenofovir disoproxil
Marketing-authorisation applicantKRKA, d.d., Novo mesto
Therapeutic indicationTreatment of HIV infection in adults
More information PDF iconSummary of opinion for Emtricitabine / Tenofovir Krka

Name of medicineTenofovir disoproxil Mylan
INNtenofovir disoproxil
Marketing-authorisation applicantMYLAN S.A.S.
Therapeutic indicationTreatment of HIV infection in adults
More information PDF iconSummary of opinion for Tenofovir disoproxil Mylan

Positive recommendations on extensions of therapeutic indications

Name of medicineLucentis
INNranibizumab
Marketing-authorisation holderNovartis Europharm Ltd
More information PDF iconSummary of opinion for Lucentis

Name of medicineOpdivo
INNnivolumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More information PDF iconSummary of opinion for Opdivo

Name of medicineTrisenox
INNarsenic trioxide
Marketing-authorisation holderTeva B.V.
More information PDF iconSummary of opinion for Trisenox

Name of medicineZebinix
INNeslicarbazepine acetate
Marketing-authorisation holderBIAL - Portela & Ca, S.A.
More information PDF iconSummary of opinion for Zebinix

Public-health recommendations

Name of the procedureMetformin and metformin-containing medicines
More information

Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function

Name of the procedureKeppra
INNlevetiracetam
Marketing-authorisation holderUCB Pharma SA
More informationEMA recommends measures to ensure safe use of Keppra oral solution

Withdrawals of application

Name of medicineErtapenem Hospira
INNertapenem
More information PDF iconQuestions and answers on the withdrawal of the marketing authorisation application for Ertapenem Hospira

Name of medicinePemetrexed ditromethamine Hospira
INNpemetrexed
More information PDF iconQuestions and answers on the withdrawal of the marketing authorisation application for Pemetrexed ditromethamine Hospira

Name of medicineZemfirza
INNcediranib
More information PDF iconQuestions and answers on the withdrawal of the marketing authorisation application for Zemfirza

Other updates

PDF iconRecommendations on eligibility to PRIME scheme
PDF iconScientific advice and protocol assistance
PDF iconOverview of (invented) names reviewed in September 2016 by the Name Review Group (NRG)

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