Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2013

This page provides an overview of the opinions adopted at the July 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

At its July meeting, the CHMP welcomed Ivana Mikacic as the Croatian member of the Committee following the accession of Croatia to the European Union on 1 July 2013. Ana Dugonjic has been appointed as the Croatian alternate. This addition brings the total number of CHMP members to 33.

Eight new medicines recommended for approval

The CHMP recommended the approval of Giotrif for the treatment of lung cancer.

The CHMP also recommended that Incresync, Vipdomet and Vipidia should be granted marketing authorisations for the treatment of type-2 diabetes.

Ultibro Breezhaler and Xoterna Breezhaler received positive opinions from the Committee for the treatment of chronic obstructive pulmonary disease (COPD).

The Committee recommended that Tybost should be granted a marketing authorisation for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in combination with the protease inhibitors atazanavir and darunavir.

The Committee also gave a positive recommendation for the approval of Grastofil, a biosimilar medicine for the treatment of neutropenia.

Negative opinion for Delamanid

The Committee adopted a negative opinion for Delamanid, which was intended for the treatment of multi-drug-resistant tuberculosis.

Seven recommendations on extensions of therapeutic indications

The CHMP recommended extensions to the existing indications for Eylea, Ilaris, Prezista, Revolade, Simponi, Stelara and Zonegran.

Re-examination of two initial recommendations for marketing authorisation

The CHMP adopted a positive re-examination opinion for Defitelio, for the treatment of severe hepatic veno-occlusive disease (VOD) in patients undergoing blood-stem-cell transplantation.

It also adopted a final negative opinion following the re-examination of Xeljanz which was intended for the treatment of moderate to severe active rheumatoid arthritis.

Investigation on GLP-1 based diabetes therapies concluded

The CHMP has finalised a review of glucagon-like-peptide-1 (GLP-1)-based diabetes therapies. The Committee concluded that available data do not confirm recent concerns over an increased pancreatic cancer risk with these medicines. For more information, please see the press release in the grid below.

Outcome of two further safety reviews

In addition to the safety review on GLP-1-based diabetes therapies, the Committee also issued recommendations on ketoconazole-containing medicines for oral use and metoclopramide-containing medicines.

More information on these and all other outcomes of this month's meeting are available in the table below.

Positive recommendations on new medicines

Name of medicine	Giotrif
International non-proprietary name (INN)	afatinib
Marketing-authorisation applicant	Boehringer Ingelheim International GmbH
Therapeutic indication	Treatment of epidermal-growth-factor-receptor (EGFR) tyrosine-kinase-inhibitor-naïve adult patients with locally advanced or metastatic non-small-cell lung cancer with activating EGFR mutations
More information	CHMP summary of positive opinion for Giotrif

Name of medicine	Grastofil
International non-proprietary name (INN)	filgrastim
Marketing-authorisation applicant	Apotex Europe BV
Therapeutic indication	Treatment of neutropenia
More information	CHMP summary of positive opinion for Grastofil

Name of medicine	Incresync
INN	alogliptin / pioglitazone
Marketing-authorisation applicant	Takeda Pharma A/S
Therapeutic indication	Treatment of type-2 diabetes mellitus
More information	CHMP summary of positive opinion for Incresync

Name of medicine	Tybost
INN	cobicistat
Marketing-authorisation applicant	Gilead Sciences International Ltd
Therapeutic indication	Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in HIV-1-infected adults
More information	CHMP summary of positive opinion for Tybost

Name of medicine	Ultibro Breezhaler
INN	glycopyrronium bromide / indacaterol
Marketing-authorisation applicant	Novartis Europharm Ltd
Therapeutic indication	Treatment of COPD
More information	CHMP summary of positive opinion for Ultibro Breezhaler

Name of medicine	Vipdomet
INN	alogliptin / metformin
Marketing-authorisation applicant	Takeda Pharma A/S
Therapeutic indication	Treatment of type-2 diabetes mellitus
More information	CHMP summary of positive opinion for Vipdomet

Name of medicine	Vipidia
INN	alogliptin
Marketing-authorisation applicant	Takeda Pharma A/S
Therapeutic indication	Treatment of type-2 diabetes mellitus
More information	CHMP summary of positive opinion for Vipidia

Name of medicine	Xoterna Breezhaler
INN	glycopyrronium bromide / indacaterol
Marketing-authorisation applicant	Novartis Europharm Ltd
Therapeutic indication	Treatment of COPD
More information	CHMP summary of positive opinion for Xoterna Breezhaler

Negative recommendation on new medicine

Name of medicine	Delamanid
INN	delamanid
Marketing-authorisation applicant	Otsuka Novel Products GmbH
Therapeutic indication	Treatment of multi-drug-resistant tuberculosis
More information	Questions and answers on refusal of the marketing authorisation for Delamanid

Re-examinations of initial recommendations for marketing authorisation

Name of medicine	Defitelio
INN	defibrotide
Marketing-authorisation applicant	Gentium S.p.A.
Therapeutic indication	Treatment of severe VOD in patients undergoing blood-stem-cell transplantation
More information	CHMP summary of positive opinion for Defitelio Questions and answers on the positive opinion on the marketing authorisation for Defitelio (defibrotide) - Outcome of re-examination

Name of medicine	Xeljanz
INN	tofacitinib
Marketing-authorisation applicant	Pfizer Limited
Therapeutic indication	Treatment of moderate to severe active rheumatoid arthritis
More information	Questions and answers on refusal of the marketing authorisation for Xeljanz - Outcome of re-examination

Positive recommendations on extensions of therapeutic indications

Name of medicine	Eylea
INN	aflibercept
Marketing-authorisation holder	Bayer Pharma AG
Change to the indication (changes in bold)	Eylea is indicated for adults for the treatment of: - neovascular (wet) age-related macular degeneration (see section 5.1); - visual impairment due to macular oedema secondary to central-retinal-vein occlusion (see section 5.1).
More information	CHMP post-authorisation summary of positive opinion for Eylea

Name of medicine	Ilaris
INN	canakinumab
Marketing-authorisation holder	Novartis Europharm Ltd.
Change to the indication (changes in bold)	Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes in adults, adolescents and children aged two years and older with body weight of 7.5 kg or above, including: - Muckle-Wells syndrome (MWS); - neonatal-onset multisystem inflammatory disease / chronic infantile neurological, cutaneous, articular syndrome; - severe forms of familial cold auto-inflammatory syndrome / familial cold urticaria presenting with signs and symptoms beyond cold-induced urticarial skin rash - Ilaris is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients aged two years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate.
More information	CHMP post-authorisation summary of positive opinion for Ilaris

Name of medicine	Prezista
INN	darunavir
Marketing-authorisation holder	Janssen-Cilag International N.V.
Change to the indication (changes in bold)	Prezista 400- and 800-mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 12 years and at least 40 kg body weight who are: - antiretroviral-therapy (ART)-naïve (see section 4.2); - ART-experienced with no darunavir-resistance-associated mutations and who have plasma HIV-1 RNA 100,000 copies/ml and CD4+ cell count ? 100 cells x 10⁶/l. In deciding to initiate treatment with Prezista in such ART-experienced patients, genotypic testing should guide the use of Prezista (see sections 4.2, 4.3, 4.4 and 5.1).
More information	CHMP post-authorisation summary of positive opinion for Prezista

Name of medicine	Revolade
INN	eltrombopag
Marketing-authorisation holder	GlaxoSmithKline Trading Services
Change to the indication (changes in bold)	- Revolade is indicated for adult chronic-immune (idiopathic)-thrombocytopenic-purpura splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Revolade may be considered as second-line treatment for adult non-splenectomised patients where surgery is contraindicated. - Revolade is indicated in adult patients with chronic hepatitis-C-virus infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy.
More information	CHMP post-authorisation summary of positive opinion for Revolade

Name of medicine	Simponi
INN	golimumab
Marketing-authorisation holder	Janssen Biologics B.V.
Change to the indication (changes in bold)	Rheumatoid arthritis (RA) Simponi, in combination with methotrexate (MTX), is indicated for: - the treatment of moderate to severe, active RA in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate; - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Psoriatic arthritis (PsA) Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive PsA in adult patients when the response to previous DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Ankylosing spondylitis (AS) Simponi is indicated for the treatment of severe, active AS in adults who have responded inadequately to conventional therapy. *Ulcerative colitis (UC)* Simponi is indicated for treatment of moderately to severely active UC in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6?mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies.
More information	CHMP post-authorisation summary of positive opinion for Simponi

Name of medicine	Stelara
INN	ustekinumab
Marketing-authorisation holder	Janssen-Cilag International N.V.
Change to the indication (changes in bold)	Plaque psoriasis Stelara is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, MTX and psoralen ultraviolet A (see section 5.1). *PsA* Stelara, alone or in combination with MTX, is indicated for the treatment of active PsA in adult patients when the response to previous non-biological DMARD therapy has been inadequate (see section 5.1).
More information	CHMP post-authorisation summary of positive opinion for Stelara

Name of medicine	Zonegran
INN	zonisamide
Marketing-authorisation holder	Eisai Ltd
Extension of indication (changes in bold)	Zonegran is indicated as: - monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; - adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents and children aged six years and above.
More information	CHMP post-authorisation summary of positive opinion for Zonegran

Recommendation on other variations

Name of medicine	Insuman
INN	insulin human
Marketing-authorisation holder	Sanofi-aventis Deutschland GmbH
More information	CHMP post-authorisation summary of positive opinion for Insuman

Withdrawal of applications

Name of medicine	Effentora
INN	fentanyl citrate
More information	Effentora: Withdrawn application

Name of medicine	Eviplera
INN	emtricitabine / rilpivirine hydrochloride / tenofovir disoproxil fumarate
More information	Eviplera: Withdrawn application

Outcome of arbitration procedure

Name of medicine	Methylphenidate Hexal
INN	methylphenidate hydrochloride
Marketing-authorisation holder	Hexal A/S
More information	Methylphenidate Hexal: Article-29 referral

Name of medicine	Methylphenidate Sandoz
INN	methylphenidate hydrochloride
Marketing-authorisation holder	Sandoz A/S
More information	Methylphenidate Sandoz: Article-29 referral

Opinion on any scientific matter (Article 5(3))

Name of medicine	GLP-1 based therapies
INN	exenatide, liraglutide, lixisenatide, sitagliptin, saxagliptin, vildagliptin, linagliptin
More information	Investigation into GLP-1-based diabetes therapies concluded

Public-health communications on non-centrally authorised medicines

Name of medicine	Ketoconazole-containing medicines for oral use
INN	ketoconazole
More information	Ketoconazole-containing medicines: Article-31 referral European Medicines Agency recommends suspension of marketing authorisations for oral ketoconazole

Name of medicine

Ketoconazole-containing medicines for oral use

INN

ketoconazole

More information

Ketoconazole-containing medicines: Article-31 referral

European Medicines Agency recommends suspension of marketing authorisations for oral ketoconazole