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 |
|
Name of medicine | Grastofil |
---|---|
International non-proprietary name (INN) | filgrastim |
Marketing-authorisation applicant | Apotex Europe BV |
Therapeutic indication | Treatment of neutropenia |
More information |
|
Name of medicine | Incresync |
---|---|
INN | alogliptin / pioglitazone |
Marketing-authorisation applicant | Takeda Pharma A/S |
Therapeutic indication | Treatment of type-2 diabetes mellitus |
More information |
|
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 |
|
Name of medicine | Ultibro Breezhaler |
---|---|
INN | glycopyrronium bromide / indacaterol |
Marketing-authorisation applicant | Novartis Europharm Ltd |
Therapeutic indication | Treatment of COPD |
More information |
|
Name of medicine | Vipdomet |
---|---|
INN | alogliptin / metformin |
Marketing-authorisation applicant | Takeda Pharma A/S |
Therapeutic indication | Treatment of type-2 diabetes mellitus |
More information |
|
Name of medicine | Vipidia |
---|---|
INN | alogliptin |
Marketing-authorisation applicant | Takeda Pharma A/S |
Therapeutic indication | Treatment of type-2 diabetes mellitus |
More information |
|
Name of medicine | Xoterna Breezhaler |
---|---|
INN | glycopyrronium bromide / indacaterol |
Marketing-authorisation applicant | Novartis Europharm Ltd |
Therapeutic indication | Treatment of COPD |
More information |
|
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 |
|
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 |
|
Name of medicine | Xeljanz |
---|---|
INN | tofacitinib |
Marketing-authorisation applicant | Pfizer Limited |
Therapeutic indication | Treatment of moderate to severe active rheumatoid arthritis |
More information |
|
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 |
|
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 |
|
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 |
|
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 |
|
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: 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 |
|
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 |
|
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 |
|
Recommendation on other variations
Name of medicine | Insuman |
---|---|
INN | insulin human |
Marketing-authorisation holder | Sanofi-aventis Deutschland GmbH |
More information |
|
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 | Metoclopramide-containing medicines |
---|---|
INN | metoclopramide |
More information | Metoclopramide-containing medicines: Article-31 referral
European Medicines Agency recommends changes to the use of metoclopramide |
Other updates
Related content
- Bydureon: EPAR
- Byetta: EPAR
- Defitelio: EPAR
- Deltyba: EPAR
- Effentora: EPAR
- Efficib: EPAR
- Eucreas: EPAR
- Eviplera: EPAR
- Eylea: EPAR
- Galvus: EPAR
- Giotrif: EPAR
- Grastofil: EPAR
- Icandra (previously Vildagliptin / metformin hydrochloride Novartis): EPAR
- Ilaris: EPAR
- Incresync: EPAR
- Insuman: EPAR
- Jalra: EPAR
- Janumet: EPAR
- Januvia: EPAR
- Jentadueto: EPAR
- Komboglyze: EPAR
- Lyxumia : EPAR
- Onglyza: EPAR
- Prezista: EPAR
- Revolade: EPAR
- Ristaben: EPAR
- Ristfor: EPAR
- Simponi: EPAR
- Stelara: EPAR
- Tesavel: EPAR
- Trajenta: EPAR
- Tybost: EPAR
- Ultibro Breezhaler: EPAR
- Velmetia: EPAR
- Victoza: EPAR
- Vipdomet: EPAR
- Vipidia: EPAR
- Xelevia: EPAR
- Xeljanz: EPAR
- Xiliarx: EPAR
- Xoterna Breezhaler: EPAR
- Zomarist: EPAR
- Zonegran: EPAR