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

Download image in PDF format

Positive recommendations on new medicines

Name of medicine	Feraccru
INN	ferric maltol
Marketing-authorisation applicant	Iron Therapeutics (UK) Ltd
Therapeutic indication	Treatment of iron deficiency anaemia in patients with inflammatory bowel disease
More information	Summary of opinion for Feraccru

Name of medicine	Iblias
INN	octocog alfa
Marketing-authorisation applicant	Bayer Pharma AG
Therapeutic indication	Treatment and prophylaxis of bleeding in patients with haemophilia A
More information	Summary of opinion for Iblias

Name of medicine	Kovaltry
INN	octocog alfa
Marketing-authorisation applicant	Bayer Pharma AG
Therapeutic indication	Treatment and prophylaxis of bleeding in patients with haemophilia A
More information	Summary of opinion for Kovaltry

Name of medicine	Portrazza
INN	necitumumab
Marketing-authorisation applicant	Eli Lilly Nederland B.V.
Therapeutic indication	Treatment of squamous non-small cell lung cancer
More information	Summary of opinion for Portrazza

Name of medicine	Vaxelis
INN	diphtheria, tetanus, pertussis (acellular, component), hepatitis b (rdna), poliomyelitis (inact.) and haemophilus type b conjugate vaccine (adsorbed)
Marketing-authorisation applicant	Sanofi Pasteur MSD SNC
Therapeutic indication	Intended for prophylaxis against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B
More information	Summary of opinion for Vaxelis

Name of medicine	Zurampic
INN	lesinurad
Marketing-authorisation applicant	AstraZeneca AB
Therapeutic indication	Treatment of hyperuricaemia
More information	Summary of opinion for Zurampic

Negative recommendation on new medicine

Name of medicine	Dropcys
INN	mercaptamine hydrochloride
Marketing-authorisation applicant	Lucane Pharma
Therapeutic indication	Treatment of corneal cystine deposits
More information	Questions and answers on Dropcys

Positive recommendation on new generic medicine

Name of medicine	Caspofungin Accord
INN	caspofungin
Marketing-authorisation applicant	Accord Healthcare Ltd
Therapeutic indication	Treatment of fungal infections
More information	Summary of opinion for Caspofungin Accord

Positive recommendation on new hybrid medicine

Name of medicine	Neofordex
INN	dexamethasone
Marketing-authorisation applicant	Laboratoires CTRS
Therapeutic indication	Treatment of multiple myeloma
More information	Summary of opinion for Neofordex

Positive recommendations on extensions of therapeutic indications

Name of medicine	Brilique
INN	ticagrelor
Marketing-authorisation holder	AstraZeneca AB
More information	Summary of opinion for Brilique

Name of medicine	Cyramza
INN	ramucirumab
Marketing-authorisation holder	Eli Lilly Nederland B.V.
More information	Summary of opinion for Cyramza

Name of medicine	Nplate
INN	romiplostim
Marketing-authorisation holder	Amgen Europe B.V.
More information	Summary of opinion for Nplate

Name of medicine	Revolade
INN	eltrombopag / eltrombopag olamine
Marketing-authorisation holder	Novartis Europharm Ltd
More information	Summary of opinion for Revolade

Name of medicine	Tarceva
INN	erlotinib
Marketing-authorisation holder	Roche Registration Ltd
More information	Summary of opinion for Tarceva

Public health recommendation

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures

Opinions on safety variations

Start of Community reviews

Scientific advice and protocol assistance

Guidelines and concept papers adopted

Overview of invented names reviewed in November 2015 by the Name Review Group (NRG)

Organisational matters

Opinions on consultation procedures on ancillary medicinal substances in medical devices