Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 December 2015

News 18/12/2015

Nine medicines recommended for authorisation, 93 overall in 2015

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended nine new medicines for marketing authorisation at its December 2015 meeting. This brings the total number of medicines recommended for approval by the CHMP in 2015 to 93.

The CHMP recommended granting a conditional marketing authorisation for Tagrisso (osimertinib) for the treatment of non-small cell lung cancer (NSCLC). The Committee reviewed Tagrisso under EMA's accelerated assessment program. Conditional approval and accelerated assessment are two of the Agency's main mechanisms to facilitate earlier access by patients to medicines that fulfil unmet medical needs. For more information, please see the press release in the grid below.

Another medicine for NSCLC, Portrazza (necitumumab), also received a positive opinion from the Committee.

Neofordex (dexamethasone), a medicine with an orphan designation, received a positive opinion for the treatment of symptomatic multiple myeloma. Neofordex was submitted as a hybrid application. This type of application relies in part on the results of studies carried out with a reference product and in part on new data.

The CHMP recommended granting a marketing authorisation for Feraccru (ferric maltol) for the treatment of iron deficiency anaemia in patients with inflammatory bowel disease.

Zurampic (lesinurad) received a positive opinion from the Committee for the treatment of hyperuricaemia (an excess of uric acid in the blood).

The CHMP recommended granting a marketing authorisation for Vaxelis, a vaccine against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B.

Iblias and Kovaltry (octocog alfa) received positive opinions for the treatment and prophylaxis of bleeding in patients with haemophilia A. These are duplicate applications, meaning that the company provided the same sets of clinical data to support the marketing authorisation applications of both medicines.

One generic medicine received a positive opinion from the Committee: Caspofungin Accord (caspofungin) for the treatment of fungal infections.

Negative opinion on new medicine

The CHMP adopted a negative opinion for Dropcys (mercaptamine hydrochloride) which was intended to prevent and treat cystinosis affecting the eye. For more information, please see the questions-and-answers document in the grid below.

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Brilique, Nplate, Revolade, Tarceva and two extensions of indication for Cyramza.

New advice for doctors and patients on Gilenya

The CHMP gave new advice for doctors and patients to minimise the risk of progressive multifocal leukoencephalopathy (PML) and basal cell carcinoma in patients treated with the multiple sclerosis medicine Gilenya (fingolimod). For more information, please see the public health communication in the grid below.

Update on Xarelto

The CHMP is currently evaluating whether a defect with a blood clotting test device used in a study of the anti-clotting medicine Xarelto (rivaroxaban) had an impact on the study results. The study, called ROCKET-AF, was used to support the approval of Xarelto for patients with non-valvular atrial fibrillation (a type of irregular heartbeat). The CHMP expects to conclude its assessment in the first quarter of 2016. Once finalised, the CHMP assessment report will be made public.

Agenda and minutes

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

CHMP statistics

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

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

 December 2015

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Positive recommendations on new medicines

Name of medicineFeraccru
INNferric maltol
Marketing-authorisation applicantIron Therapeutics (UK) Ltd
Therapeutic indicationTreatment of iron deficiency anaemia in patients with inflammatory bowel disease
More information PDF iconSummary of opinion for Feraccru

Name of medicineIblias
INNoctocog alfa
Marketing-authorisation applicantBayer Pharma AG
Therapeutic indicationTreatment and prophylaxis of bleeding in patients with haemophilia A
More information PDF iconSummary of opinion for Iblias

Name of medicineKovaltry
INNoctocog alfa
Marketing-authorisation applicantBayer Pharma AG
Therapeutic indicationTreatment and prophylaxis of bleeding in patients with haemophilia A
More information PDF iconSummary of opinion for Kovaltry

Name of medicinePortrazza
INNnecitumumab
Marketing-authorisation applicantEli Lilly Nederland B.V.
Therapeutic indicationTreatment of squamous non-small cell lung cancer
More information PDF iconSummary of opinion for Portrazza

Name of medicineTagrisso
INNosimertinib
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationTreatment of non-small cell lung cancer
More information

PDF iconSummary of opinion for Tagrisso

Press release: EMA fast-tracks new oral treatment for non-small cell lung cancer

Name of medicineVaxelis
INNdiphtheria, tetanus, pertussis (acellular, component), hepatitis b (rdna), poliomyelitis (inact.) and haemophilus type b conjugate vaccine (adsorbed)
Marketing-authorisation applicantSanofi Pasteur MSD SNC
Therapeutic indicationIntended for prophylaxis against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B
More information PDF iconSummary of opinion for Vaxelis

Name of medicineZurampic
INNlesinurad
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationTreatment of hyperuricaemia
More information PDF iconSummary of opinion for Zurampic

Negative recommendation on new medicine

Name of medicineDropcys
INNmercaptamine hydrochloride
Marketing-authorisation applicantLucane Pharma
Therapeutic indicationTreatment of corneal cystine deposits
More information PDF iconQuestions and answers on Dropcys

Positive recommendation on new generic medicine

Name of medicineCaspofungin Accord
INNcaspofungin
Marketing-authorisation applicantAccord Healthcare Ltd
Therapeutic indicationTreatment of fungal infections
More information PDF iconSummary of opinion for Caspofungin Accord

Positive recommendation on new hybrid medicine

Name of medicineNeofordex
INNdexamethasone
Marketing-authorisation applicantLaboratoires CTRS
Therapeutic indicationTreatment of multiple myeloma
More information PDF iconSummary of opinion for Neofordex

Positive recommendations on extensions of therapeutic indications

Name of medicineBrilique
INNticagrelor
Marketing-authorisation holderAstraZeneca AB
More information PDF iconSummary of opinion for Brilique

Name of medicineCyramza
INNramucirumab
Marketing-authorisation holderEli Lilly Nederland B.V.
More information PDF iconSummary of opinion for Cyramza

Name of medicineNplate
INNromiplostim
Marketing-authorisation holderAmgen Europe B.V.
More information PDF iconSummary of opinion for Nplate

Name of medicineRevolade
INNeltrombopag / eltrombopag olamine
Marketing-authorisation holderNovartis Europharm Ltd
More information PDF iconSummary of opinion for Revolade

Name of medicineTarceva
INNerlotinib
Marketing-authorisation holderRoche Registration Ltd
More information PDF iconSummary of opinion for Tarceva

Public health recommendation

Name of medicineGilenya
INNfingolimod
Marketing-authorisation holderNovartis Europharm Ltd
More informationNew recommendations to minimise risks of the rare brain infection PML and a type of skin cancer with Gilenya

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
PDF iconOverview of invented names reviewed in November 2015 by the Name Review Group (NRG)
PDF iconOrganisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

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