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

 

London, UK (May 25, 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 months’ 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

Glaxco 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



Outcome of review of centrally authorised medicine related to manufacturing issue

 

Name of medicine

INN

Marketing authorisation holder

 

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

Questions and answers on the review 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



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 during the May 2012 CHMP meeting

Organisational matters

 


 

European Medicines Agency (EMA), 25.05.2012 (tB)

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