Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2016

News 16/12/2016

Seven medicines recommended for authorisation, 81 overall in 2016

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for marketing authorisation at its December 2016 meeting. This brings the total number of medicines recommended for approval by the CHMP in 2016 to 811.

The CHMP recommended granting a marketing authorisation to Olumiant (baricitinib) for the treatment of moderate to severe active rheumatoid arthritis. For more information, please see the press release in the grid below.

The CHMP recommended granting a conditional marketing authorisation for Alecensa (alectinib) for the treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.

Lifmior (etanercept) received a positive recommendation from the Committee for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis.

A biosimilar medicine, Truxima (rituximab), received a positive opinion from the CHMP for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

One hybrid medicine, Ledaga (chormethine), received a positive opinion for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data. Ledaga has an orphan designation.

A generic medicine, Pregabalin Zentiva k.s (pregabalin), received a positive opinion from the Committee for the treatment of epilepsy, neuropathic pain and generalised anxiety disorder.

The CHMP also granted a positive opinion for the informed consent application for Vihuma (simoctocog alfa) for the prevention and treatment of bleeding in patients with haemophilia A (congenital factor VIII deficiency). In an informed consent application, reference is made to an authorised medicine and the marketing authorisation holder of the reference medicine has given consent to the use of their dossier in the application procedure.

Positive opinion on Zinplava adopted by written procedure

In addition to the positive opinions for the seven new medicines adopted at the December 2016 meeting, the CHMP recommended granting a marketing authorisation for Zinplava (bezlotoxumab) to prevent the recurrence of Clostridium difficile infection via written procedure on 22 November 2016.

Nine recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Ameluz, Cinryze,Ilaris, Jardiance, Jentadueto, Keytruda, Tivicay, Trajenta and Votubia.

Start of referral: Micro Therapeutics Research Labs, India

The CHMP started a review of medicinesfor which studies have been conducted by Micro Therapeutic Research Labs at two sites in India. This follows a good clinical practice inspection which raised concerns about the study data used to support marketing authorisation applications of some medicines in the European Union. For more information, please see the start of referral document in the grid below.

Outcome of review of direct-acting antivirals

The CHMP confirmed the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) to screen all patients for hepatitis B before starting treatment with direct-acting antivirals for hepatitis C; patients infected with both hepatitis B and C viruses must be monitored and managed according to current clinical guidelines. These measures aim to minimise the risk of hepatitis B re-activation with direct-acting antivirals. For more information, please see the public health communication in the grid below.

Withdrawals of applications

Applications for marketing authorisations for Cavoley (pegfilgrastim), Efgratin (pegfilgrastim), Graspa (eryaspase) and Kepnetic (aceneuramic acid) have been withdrawn. Questions-and-answers documents on these withdrawals are available in the grid below.

A request to extend the indication of Arzerra (ofatumumab) to be used in a new combination with bendamustine for the treatment of relapsed chronic lymphocytic leukaemia has been withdrawn. A questions-and-answers document on this withdrawal is available below.

Agenda and minutes

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

CHMP statistics

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

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

More cumulative figures can be found on the medicine evaluation figures page.


1EMA will publish its human medicines highlights for 2016 in early 2017.

Download image in PDF format

Positive recommendations on new medicines

Name of medicineAlecensa
International non-proprietary name (INN)alectinib
Marketing-authorisation applicantRoche Registration Limited
Therapeutic indicationTreatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib
More information PDF iconSummary of opinion for Alecensa

Name of medicineLifmior
INNetanercept
Marketing-authorisation applicantPfizer Limited
Therapeutic indicationTreatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis
More information PDF iconSummary of opinion for Lifmior

Name of medicineOlumiant
INNbaricitinib
Marketing-authorisation applicantEli Lilly Nederland B.V.
Therapeutic indicationTreatment of rheumatoid arthritis

PDF iconSummary of opinion for Olumiant

Press release: New oral treatment for rheumatoid arthritis

Positive recommendation on new informed-consent application

Name of medicineVihuma
INNsimoctocog alfa
Marketing-authorisation applicantOctapharma AB
Therapeutic indicationTreatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)
More information PDF iconSummary of opinion for Vihuma

Positive recommendation on new generic medicine

Name of medicinePregabalin Zentiva k.s.
INNpregabalin
Marketing-authorisation applicantZentiva k.s.
Therapeutic indicationTreatment of neuropathic pain, epilepsy and generalised anxiety disorder
More information PDF iconSummary of opinion for Pregabalin Zentiva k.s.

Positive recommendation on new hybrid medicine

Name of medicineLedaga
INNchlormethine
Marketing-authorisation applicantActelion Registration Ltd
Therapeutic indicationTreatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL)
More information PDF iconSummary of opinion for Ledaga

Positive recommendation on new biosimilar medicine

Name of medicineTruxima
INNrituximab
Marketing-authorisation applicantCelltrion Healthcare Hungary Kft.
Therapeutic indicationTreatment of Non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis and granulomatosis with polyangiitis and microscopic polyangiitis
More information PDF iconSummary of opinion for Truxima

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 medicineCinryze
INNc1-esterase inhibitor, human
Marketing-authorisation holderShire Services BVBA
More information PDF iconSummary of opinion for Cinryze

Name of medicineIlaris
INNcanakinumab
Marketing-authorisation holderNovartis Europharm Ltd
More information PDF iconSummary of opinion for Ilaris

Name of medicineJardiance
INNempagliflozin
Marketing-authorisation holderBoehringer Ingelheim International GmbH
More information PDF iconSummary of opinion for Jardiance

Name of medicineJentadueto
INNlinagliptin / metformin
Marketing-authorisation holderBoehringer Ingelheim International GmbH
More information PDF iconSummary of opinion for Jentadueto

Name of medicineKeytruda
INNpembrolizumab
Marketing-authorisation holderMerck Sharp & Dohme Limited
More information PDF iconSummary of opinion for Keytruda

Name of medicineTivicay
INNdolutegravir
Marketing-authorisation holderViiV Healthcare UK Limited
More information PDF iconSummary of opinion for Tivicay

Name of medicineTrajenta
INNlinagliptin
Marketing-authorisation holderBoehringer Ingelheim International GmbH
More information PDF iconSummary of opinion for Trajenta

Name of medicineVotubia
INNeverolimus
Marketing-authorisation holderNovartis Europharm Ltd
More information PDF iconSummary of opinion for Votubia

Start of referral

Name of medicineMicro Therapeutics Research Labs, India
More informationStart of a review concerning the conduct of studies at Micro Therapeutic Research Labs, India

Public health recommendation

Name of medicineDirect-acting antivirals indicated for the treatment of hepatitis C (interferon free)
More informationDirect-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B

Outcome of harmonisation procedure

Name of medicineLovenox and associated names
INNenoxaparin
More informationQuestions and answers on Lovenox and associated names (enoxaparin, solution for injection)

Withdrawals of applications

Name of medicineArzerra
INNofatumumab
More information PDF iconQuestions and answers on Arzerra

Name of medicineCavoley
INNpegfilgrastim
More information PDF iconQuestions and answers on Cavoley

Name of medicineEfgratin
INNpegfilgrastim
More information PDF iconQuestions and answers on Efgratin

Name of medicineGraspa
INNeryaspase
More information PDF iconQuestions and answers on Graspa

Name of medicineKepnetic
INNaceneuramic acid
More information PDF iconQuestions and answers on Kepnetic

Other outcomes

Name of medicineInovelon
INNrufinamide
Marketing-authorisation holderEisai Ltd
More information PDF iconQuestions and answers on Inovelon

Name of medicineRepatha
INNevolocumab
Marketing-authorisation holderAmgen Europe B.V.
More information PDF iconSummary of opinion for Repatha

Other updates

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

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