European Medicines Agency - News and Events - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 May 2012

25/05/2012

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 May 2012

This page lists the opinions adopted at the May 2012 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

Users can view the main opinions adopted at the meeting, along with information on referral procedures, in a clear tabular format. Users can click on the links within the page to read individual press releases and more detailed information about the opinions.

This month's highlights introduce changes based on feedback from journalists and other stakeholders over the last seven months:

the CHMP highlights now lists therapeutic indications for opinions for new medicines and for extensions of indications;
the annex on new marketing authorisation has been disbanded. This information is available on the European public assessment report (EPAR) page (to view the latest marketing authorisations, select 'View All' and sort by date);
procedural announcements are now published as news items on the homepage and under news for industry.

The Agency publishes a new page following each month's CHMP meeting.

Positive opinions on new medicines

Name of medicine	Bretaris Genuair / Eklira Genuair
International non-proprietary name (INN)	aclidinium bromide
Marketing authorisation applicant	Almirall, S.A.
Therapeutic indication	Maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease.
More information	Summary of opinion for Bretaris Genuair Summary of opinion for Eklira Genuair

Name of medicine	Fycompa
International non-proprietary name (INN)	perampanel
Marketing authorisation applicant	Eisai Europe Ltd
Therapeutic indication	Adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.
More information	Summary of opinion for Fycompa

Name of medicine	Inlyta
International non-proprietary name (INN)	axitinib
Marketing authorisation applicant	Pfizer Ltd
Therapeutic indication	Treatment of adult patients with advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine.
More information	Summary of opinion for Inlyta

Name of medicine	Jentadueto
International non-proprietary name (INN)	linagliptin / metformin
Marketing authorisation applicant	Boehringer Ingelheim International GmbH
Therapeutic indication	Treatment of adult patients with type 2 diabetes mellitus: Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin. Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
More information	Summary of opinion for Jentadueto

Name of medicine	Kalydeco
International non-proprietary name (INN)	ivacaftor
Marketing authorisation applicant	Vertex Pharmaceuticals (UK) Ltd
Therapeutic indication	Treatment of cystic fibrosis in patients age 6 years and older who have a G551D mutation in the CFTR gene.
More information	Summary of opinion for Kalydeco
Press release	European Medicines Agency recommends first-in-class medicine for treatment of cystic fibrosis

Name of medicine	Novothirteen
International non-proprietary name (INN)	catridecacog
Marketing authorisation applicant	Novo Nordisk A/S
Therapeutic indication	Long term prophylactic treatment of bleeding in patients 6 years and above with congenital factor XIII A-subunit deficiency.
More information	Summary of opinion for Novothirteen

Positive opinions on new generic medicines

Name of medicine	Zoledronic acid Medac
International non-proprietary name (INN)	zoledronic acid
Marketing authorisation applicant	medac Gesellschaft für klinische Spezialpräparate mbH
Therapeutic indication	Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. The treatment of adult patients with tumour-induced hypercalcaemia.
More information	Summary of opinion for Zoledronic acid Medac

Positive opinions on extensions of therapeutic indications

Name of medicine	Osseor / Protelos
International non-proprietary name (INN)	strontium ranelate
Marketing authorisation holder	Les Laboratoires Servier
Therapeutic indication (changes in bold)	Treatment of osteoporosis in postmenopausal women to reduce the risk of vertebral and hip fractures. Treatment of osteoporosis in men at increased risk of fracture.
More information	Summary of opinion for Osseor Summary of opinion for Protelos

Name of medicine	Votrient
International non-proprietary name (INN)	pazopanib
Marketing authorisation holder	Glaxo Group Ltd
Therapeutic indication (changes in bold)	Renal cell carcinoma - Votrient is indicated in adults for the first line treatment of advanced renal cell carcinoma and for patients who have received prior cytokine therapy for advanced disease. Soft tissue sarcoma (STS) - Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft tissue sarcoma who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes.
More information	Summary of opinion for Votrient

Name of medicine	Zonegran
International non-proprietary name (INN)	zonisamide
Marketing authorisation holder	Eisai Ltd
Therapeutic indication (changes in bold)	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 adult patients.
More information	Summary of opinion for Zonegran

Safety update of centrally authorised medicine

Name of medicine	INN	Marketing authorisation holder
Pradaxa Press release: European Medicines Agency updates patient and prescriber information for Pradaxa Questions and answers on the review of bleeding risk with Pradaxa (dabigatran etexilate)	dabigatran etexilate mesilate	Boehringer Ingelheim International GmbH

Name of medicine

INN

Marketing authorisation holder

Pradaxa

Press release: European Medicines Agency updates patient and prescriber information for Pradaxa

Questions and answers on the review of bleeding risk with Pradaxa (dabigatran etexilate)

dabigatran etexilate mesilate

Boehringer Ingelheim International GmbH

Outcome of review of centrally authorised medicine related to manufacturing issue

Name of medicine	INN	Marketing authorisation holder
MabThera Press release: European Medicines Agency confirms positive benefit-risk balance of MabThera	rituximab	Roche Registration Ltd

Name of medicine

INN

Marketing authorisation holder

MabThera

Press release: European Medicines Agency confirms positive benefit-risk balance of MabThera

rituximab

Roche Registration Ltd

Outcome of harmonisation referrals

Name of medicine	INN	Marketing authorisation holder
Flolan and associated names	epoprostenol	GSK group of companies
Tavanic and associated names	levofloxacin	Sanofi-Aventis group of companies
Zinnat and associated names	cefuroxime axetil	GSK group of companies
Zinacef and associated names	cefuroxime axetil	GSK group of companies