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

News 20/11/2015

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

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 PDF iconArt. 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.

PDF iconDownload image in PDF format

Positive recommendations on new medicines

Name of medicineBenepali
International non-proprietary name (INN)etanercept
Marketing-authorisation applicantSamsung Bioepis UK Limited (SBUK)
Therapeutic indicationTreatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis
More information PDF iconSummary of opinion for Benepali

Name of medicineBriviact
International non-proprietary name (INN)brivaracetam
Marketing-authorisation applicantUCB Pharma SA
Therapeutic indicationTreatment of partial-onset seizures
More information PDF iconSummary of opinion for Briviact

Name of medicineEpisalvan
International non-proprietary name (INN)birch bark extract
Marketing-authorisation applicantBirken AG
Therapeutic indicationTreatment of partial thickness wounds
More information PDF iconSummary of opinion for Episalvan

Name of medicineOncaspar
International non-proprietary name (INN)pegaspargase
Marketing-authorisation applicantBaxalta Innovations GmbH
Therapeutic indicationTreatment of acute lymphoblastic leukaemia
More information PDF iconSummary of opinion for Oncaspar

Name of medicineSpectrila
International non-proprietary name (INN)asparaginase
Marketing-authorisation applicantmedac Gesellschaft fuer klinische Spezialpraeparate mbH
Therapeutic indicationTreatment of acute lymphoblastic leukaemia
More information PDF iconSummary of opinion for Spectrila

Name of medicineWakix
International non-proprietary name (INN)pitolisant
Marketing-authorisation applicantBioprojet Pharma
Therapeutic indicationTreatment of narcolepsy
More information

PDF iconSummary of opinion for Wakix

Press release: Narcolepsy treatment recommended for approval

Positive recommendations on new generic medicines

Name of medicineEptifibatide Accord
International non-proprietary name (INN)eptifibatide
Marketing-authorisation applicantAccord Healthcare Limited
Therapeutic indicationPrevention of early myocardial infarction
More information PDF iconSummary of opinion for Eptifibatide Accord

Name of medicineLopinavir / Ritonavir Mylan
International non-proprietary name (INN)lopinavir / ritonavir
Marketing-authorisation applicantMylan S.A.S.
Therapeutic indicationTreatment of HIV infection in adults, adolescents and children above the age of 2 years
More information PDF iconSummary of opinion for Lopinavir / Ritonavir Mylan

Name of medicinePemetrexed Accord
International non-proprietary name (INN)pemetrexed
Marketing-authorisation applicantAccord Healthcare Ltd
Therapeutic indicationTreatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer
More information PDF iconSummary of opinion for Pemetrexed Accord

Positive recommendation on new hybrid medicine

Name of medicinePemetrexed Actavis
International non-proprietary name (INN)pemetrexed
Marketing-authorisation applicantActavis Group PTC ehf
Therapeutic indicationTreatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer
More information PDF iconSummary of opinion for Pemetrexed Actavis

Negative recommendation on new medicine

Name of medicineSolumarv
International non-proprietary name (INN)insulin human
Marketing-authorisation applicantMarvel Life Sciences Ltd
Therapeutic indicationTreatment of diabetes
More information PDF iconQuestions and answers on Solumarv

Positive recommendations on extensions of therapeutic indications

Name of medicineCimzia
INNcertolizumab pegol
Marketing-authorisation holderUCB Pharma SA
More information PDF iconSummary of opinion for Cimzia

Name of medicinePyramax
INNpyronaridine-artesunate
Marketing-authorisation holderShin Poong Pharmaceutical Co., Ltd.
More information PDF iconSummary of opinion for Pyramax

Name of medicineZutectra
INNhuman hepatitis b immunoglobulin
Marketing-authorisation holderBiotest Pharma GmbH
More information PDF iconSummary of opinion for Zutectra

Public health recommendation

Name of medicineArticle-20 procedure: Human papillomavirus (HPV) vaccines
More informationHPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS

Other updates

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations
PDF iconStart of Community reviews
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
Overview of invented names reviewed in September 2015 by the Name Review Group (NRG)
PDF iconOrganisational matters

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