Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 November 2015

 

  • Ten medicines, including a first-in-class orphan medicine for narcolepsy, recommended for authorisation in the EU

 

London, UK (November 20, 2015) – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended ten medicines for marketing authorisation at its November 2015 meeting. The CHMP recommended granting a marketing authorisation for Wakix (pitolisant) for the treatment of narcolepsy. Narcolepsy is a rare, long-term sleep disorder which affects the brain’s ability to regulate the normal sleep-wake cycle, and may occur with or without cataplexy (sudden severe muscle weakness or loss of muscle control). Wakix, a first-in-class medicine, has an orphan designation. For more information, please see the press release in the grid below.


The CHMP recommended granting a marketing authorisation for two blood cancer medicines: Oncaspar (pegaspargase) and Spectrila (asparaginase), both for the treatment of acute lymphoblastic leukaemia. Spectrila has an orphan designation.

 

Benepali (etanercept), a biosimilar, received a positive opinion for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.

 

Briviact (brivaracetam) was recommended for marketing authorisation by the Committee for the treatment of partial-onset epilepsy seizures.

 

The CHMP recommended granting a marketing authorisation to Episalvan for the treatment of partial thickness wounds in adults. The active substance of Episalvan is birch bark extract.

 

Three generic medicines received positive opinions from the Committee: Pemetrexed Accord (pemetrexed) for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer, Lopinavir / Ritonavir Mylan (lopinavir / ritonavir) for the treatment of human immunodeficiency virus (HIV) infection in adults, adolescents and children above the age of two years and Eptifibatide Accord (eptifibatide) for the prevention of early myocardial infarction.

 

One hybrid medicine, Pemetrexed Actavis (pemetrexed), received a positive opinion for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer. Hybrid applications rely in part on the results of studies carried out with a reference product and in part on new data.

 

 

Negative opinion on new medicine

 

The CHMP adopted a negative opinion for Solumarv (insulin human) which was expected to be used to treat patients with diabetes who require insulin to control their blood sugar levels. Solumarv was developed as a biosimilar medicine. For more information, please see the questions-and-answers document in the grid below.

 

 

Three recommendations on extensions of therapeutic indication

 

 

The Committee recommended extensions of indication for Cimzia and Zutectra.

 

The Committee also recommended extending the use of Pyramax, an artemisinin combination therapy for malaria which was first evaluated in 2012 under EMA’s Article 58 programme. This allows the CHMP to assess and give a scientific opinion in cooperation with the World Health Organization (WHO) for medicines intended exclusively for markets outside the European Union (EU). Through this mechanism, regulators outside the EU can use the CHMP assessment as part of their national authorisation process.

 

Find out more about Art. 58.

 

Pyramax is currently available as a film-coated tablet to treat malaria caused by P. falciparum and P. vivax in adults and children over 20 kg. These species of the malaria parasite account for the majority of cases.

 

The CHMP recommends to add a new pharmaceutical form, granules for oral suspension, and to extend the use of Pyramax in this formulation to children and infants weighing 5 kg to less than 20 kg. This provides an age-appropriate formulation for very small children.

 

The CHMP also recommended an extension of the indication for Pyramax to remove restrictions on repeated courses of treatment in patients and on its use only in areas of low malaria transmission with evidence of artemisinin resistance.

 

 

Outcome of review of human papillomavirus (HPV) vaccines

 

The CHMP has completed the review of the evidence surrounding reports of two syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women given human papillomavirus (HPV) vaccines. After due consideration, the CHMP confirmed the recent recommendation from EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) that the available evidence does not support a causal link between the vaccines and development of CRPS or POTS. Please refer to the public health communication in the grid below for more information.

 

 

Agenda and minutes

 

The agenda of the November 2015 meeting is published on EMA’s website. Minutes of the October 2015 CHMP meeting will be published next week.

 

 

CHMP statistics

 

Key figures from the November 2015 CHMP meeting are represented in the graphic below.

 

More information on this, and all other outcomes of the CHMP’s November 2015 meeting, is available in the grid below. 

 

 

EMA201115.

 

 Abb.:

 

 

Positive recommendations on new medicines

 

  • Name of medicine

Benepali

International non-proprietary name (INN)

etanercept

Marketing-authorisation applicant

Samsung Bioepis UK Limited (SBUK)

Therapeutic indication

Treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis

More information

Summary of opinion for Benepali

 

  • Name of medicine

Briviact

International non-proprietary name (INN)

brivaracetam

Marketing-authorisation applicant

UCB Pharma SA

Therapeutic indication

Treatment of partial-onset seizures

More information

Summary of opinion for Briviact

 

  • Name of medicine

Episalvan

International non-proprietary name (INN)

birch bark extract

Marketing-authorisation applicant

Birken AG

Therapeutic indication

Treatment of partial thickness wounds

More information

Summary of opinion for Episalvan

 

  • Name of medicine

Oncaspar

International non-proprietary name (INN)

pegaspargase

Marketing-authorisation applicant

Baxalta Innovations GmbH

Therapeutic indication

Treatment of acute lymphoblastic leukaemia

More information

Summary of opinion for Oncaspar

 

  • Name of medicine

Spectrila

International non-proprietary name (INN)

asparaginase

Marketing-authorisation applicant

medac Gesellschaft fuer klinische Spezialpraeparate mbH

Therapeutic indication

Treatment of acute lymphoblastic leukaemia

More information

Summary of opinion for Spectrila

 

  • Name of medicine

Wakix

International non-proprietary name (INN)

pitolisant

Marketing-authorisation applicant

Bioprojet Pharma

Therapeutic indication

Treatment of narcolepsy

More information

Summary of opinion for Wakix

 

Press release: Narcolepsy treatment recommended for approval

 

 

Positive recommendations on new generic medicines

 

  • Name of medicine

Eptifibatide Accord

International non-proprietary name (INN)

eptifibatide

Marketing-authorisation applicant

Accord Healthcare Limited

Therapeutic indication

Prevention of early myocardial infarction

More information

Summary of opinion for Eptifibatide Accord

 

  • Name of medicine

Lopinavir / Ritonavir Mylan

International non-proprietary name (INN)

lopinavir / ritonavir

Marketing-authorisation applicant

Mylan S.A.S.

Therapeutic indication

Treatment of HIV infection in adults, adolescents and children above the age of 2 years

More information

Summary of opinion for Lopinavir / Ritonavir Mylan

 

  • Name of medicine

Pemetrexed Accord

International non-proprietary name (INN)

pemetrexed

Marketing-authorisation applicant

Accord Healthcare Ltd

Therapeutic indication

Treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer

More information

Summary of opinion for Pemetrexed Accord

 

 

Positive recommendation on new hybrid medicine

 

  • Name of medicine

Pemetrexed Actavis

International non-proprietary name (INN)

pemetrexed

Marketing-authorisation applicant

Actavis Group PTC ehf

Therapeutic indication

Treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer

More information

Summary of opinion for Pemetrexed Actavis

 

 

Negative recommendation on new medicine

 

  • Name of medicine

Solumarv

International non-proprietary name (INN)

insulin human

Marketing-authorisation applicant

Marvel Life Sciences Ltd

Therapeutic indication

Treatment of diabetes

More information

Questions and answers on Solumarv

  

 

Positive recommendations on extensions of therapeutic indications

 

  • Name of medicine

Cimzia

INN

certolizumab pegol

Marketing-authorisation holder

UCB Pharma SA

More information

Summary of opinion on Cimzia

 

  • Name of medicine

Pyramax

INN

pyronaridine-artesunate

Marketing-authorisation holder

Shin Poong Pharmaceutical Co., Ltd.

More information

Summary of opinion on Pyramax

 

  • Name of medicine

Zutectra

INN

human hepatitis b immunoglobulin

Marketing-authorisation holder

Biotest Pharma GmbH

More information

Summary of opinion on Zutectra

 

 

Public health recommendation

 

  • Name of medicine

Article-20 procedure: Human papillomavirus (HPV) vaccines

More information

HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS

 

 

Other updates

 

  • Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
  • Opinions on safety variations
  • Guidelines and concept papers adopted
  • Overview of invented names reviewed in September 2015 by the Name Review Group (NRG)
  • Organisational matters

 

 


European Medicines Agency (EMA), 20.11.2015 (tB).

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