EMA

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

  • Seven medicines recommended for authorisation, 81 overall in 2016

London, GB (December 16, 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, Tivacy, 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.

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

CHMP_highlights_December_2016

Positive recommendations on new medicines


Name of medicine

Alecensa

International non-proprietary name (INN)

alectinib

Marketing-authorisation applicant

Roche Registration Limited

Therapeutic indication

Treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib

More information

Summary of opinion for Alecensa

Name of medicine

Lifmior

INN

etanercept

Marketing-authorisation applicant

Pfizer Limited

Therapeutic indication

Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis

More information

Summary of opinion for Lifmior

Name of medicine

Olumiant

INN

baricitinib

Marketing-authorisation applicant

Eli Lilly Nederland B.V.

Therapeutic indication

Treatment of rheumatoid arthritis

More information

Summary of opinion for Olumiant

Press release: New oral treatment for rheumatoid arthritis

Positive recommendation on new informed-consent application

Name of medicine

Vihuma

INN

simoctocog alfa

Marketing-authorisation applicant

Octapharma AB

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)

More information

Summary of opinion for Vihuma

Positive recommendation on new generic medicine

Name of medicine

Pregabalin Zentiva k.s.

INN

pregabalin

Marketing-authoris ation applicant

Zentiva k.s.

Therapeutic indication

Treatment of neuropathic pain, epilepsy and generalised anxiety disorder

More information

Summary of opinion for Pregabalin Zentiva k.s.

Positive recommendation on new hybrid medicine

Name of medicine

Ledaga

INN

chlormethine

Marketing-authorisation applicant

Actelion Registration Ltd

Therapeutic indication

Treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL)

More information

Summary of opinion for Ledaga

Positive recommendation on new biosimilar medicine

Name of medicine

Truxima

INN

rituximab

Marketing-authorisation applican t

Celltrion Healthcare Hungary Kft.

Therapeutic indication

Treatment of Non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis and granulomatosis with polyangiitis and microscopic polyangiitis

More information

Summary of opinion for Truxima

Positive recommendations on extensions of therapeutic indications

Name of medicine

Ameluz

INN

5-aminolevulinic acid

Market ing-authorisation holder

Biofrontera Bioscience GmbH

More information

Summary of opinion for Ameluz

Name of medicine

Cinryze

INN

c1-esterase inhibitor, human

Marketing-authorisation holder

Shire Services BVBA

More information

Summary of opinion for Cinryze

Name of medicine

Ilaris

INN

canakinumab

Marketing-authorisation holder

Novartis Europharm Ltd

More information

Summary of opinion for Ilaris

Name of medicine

Jardiance

INN

empagliflozin

Marketing-authorisation holder

Boehringer Ingelheim International GmbH

More information

Summary of opinion for Jardiance

Name of medicine

Jentadueto

INN

linagliptin / metformin

Marketing-authorisation holder

Boehringer Ingelheim International GmbH

More information

Summary of opinion for Jentadueto

Name of medicine

Keytruda

INN

pembrolizumab

Marketing-authorisation holder

Merck Sharp & Dohme Limited

More information

Summary of opinion for Keytruda

Name of medicine

Tivicay

INN

dolutegravir

Marketing-authorisation holder

ViiV Healthcare UK Limited

More information

Summary of opinion for Tivicay

Name of medicine

Trajenta

INN

linagliptin

Marketing-authorisation holder

Boehringer Ingelheim International GmbH

More information

Summary of opinion for Trajenta

Name of medicine

Votubia

INN

everolimus

Marketing-authorisation holder

Novartis Europharm Ltd

More information

Summary of opinion for Votubia

Start of referral

Name of medicine

Micro Therapeutics Research Labs, India

More information

Start of a review concerning the conduct of studies at Micro Therapeutic Research Labs, India

Public health recommendation

Name of medicine

Direct-acting antivirals indicated for the treatment of hepatitis C (interferon free)

More information

Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B

Outcome of harmonisation procedure

Name of medicine

Lovenox and associated names

INN

enoxaparin

More information

Questions and answers on Lovenox and associated names (enoxaparin, solution for injection)

Withdrawals of applications

Name of medicine

Arzerra

INN

ofatumumab

More information

Questions and answers on Arzerra

Name of medicine

Cavoley

INN

pegfilgrastim

More information

Questions and answers on Cavoley

Name of medicine

Efgratin

INN

pegfilgrastim

More information

Questions and answers on Efgratin

Name of medicine

Graspa

INN

eryaspase

More information

Questions and answers on Graspa

Name of medicine

Kepnetic

INN

aceneuramic acid

More information

Questions and answers on Kepnetic

Other outcomes

Name of medicine

Inovelon

INN

rufinamide

Marketing-authorisation holder

Eisai Ltd

More information

Questions and answers on Inovelon

Name of medicine

Repatha

INN

evolocumab

Marketing-authorisation holder

Amgen Europe B.V.

More information

Summary of opinion for Repatha

Other updates


European Medicines Agency, 16.12.2016 (tB).

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