European Medicines Agency: Committee for Medicinal Products for Human Use 26-28 June 2006

29 June 2006

Initial marketing authorisation applications
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on initial marketing authorisation for Exjade (deferasirox), from Novartis Europharm Ltd. Exjade is indicated for the treatment of chronic iron overload due to blood transfusions. EMEA review began on 18 May 2005 with an active review time of 197 days.

Similar biological medicinal products
The Committee adopted a negative opinion for Alpheon (recombinant human Interferon-alfa-2a), from BioPartners GmbH, due to major quality concerns and to differences identified between Alpheon and the reference product Roferon-A in the quality and clinical comparability exercise. Alpheon was intended for the treatment of chronic hepatitis C. EMEA review began on 21 June 2004 with an active review time of 204 days.

Questions and answers on the recommendation for the refusal of the marketing authorisation for Alpheon.

Extensions of indications
The Committee adopted positive opinions on the extension of indication of medicinal products that are already authorised in the European Union:

• DatSCAN ([¹²³I] ioflupane), from GE Healthcare Limited, to extend its indication to help differentiate probable dementia with Lewy bodies from Alzheimer's disease. DatSCAN, a diagnostic agent, was first authorised in the European Union on 27 July 2000. It is currently indicated in the diagnosis of patients with clinically uncertain Parkinsonian syndromes, to help differentiate essential tremor from Parkinsonian syndromes related to idiopathic Parkinson´s
  disease, multiple system atrophy and progressive supranuclear palsy.
• Keppra (levetiracetam), from UCB S.A., to extend its indication to monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Keppra was first authorised in the European Union on 29 September 2000. It is currently indicated as adjunctive therapy in the treatment of partial onset seizures or myoclonic seizures in patients suffering from epilepsy.

The Committee finalised arbitration procedures for generic medicinal products containing doxazosin, concluding that the benefit-risk profile of these medicines is beneficial in the agreed indications and that a marketing authorisation should be granted.

Doxazosin-containing medicines are approved in a number of EU Member States for the treatment of essential hypertension and symptomatic treatment of benign prostatic hyperplasia. The medicinal products concerned were: Cardoreg 4 mg prolonged release tablets (doxazosin as mesylate), from Pharmcom Oy, Doxagamma 4 mg prolonged release tablets (doxazosin as mesylate), from Generics UK Limited, Doxastad 4 mg prolonged release tablets (doxazosin), from Stada Arzneimittel, Doxazosin Retard “Arrow” 4 mg prolonged release tablets (doxazosin as mesylate), from Arrow Generics Ltd, Doxazosin Retard “Winthrop” 4 mg prolonged release tablets (doxazosin as mesylate), from Winthrop Pharmaceuticals UK Ltd.

The procedures were initiated under Article 29 of the Community code on human medicinal products (Directive 2001/83/EC as amended) due to concerns regarding differences in the release profile of the reference product and the generic versions.

Arbitrations under Article 29 of the Community code on human medicinal products (Directive 2001/83/EC as amended) are initiated by one or more Member States in cases where an agreement cannot be reached in the context of the mutual recognition procedure.

Referral procedures started
The Committee started an arbitration procedure under Article 29 of the Community code on human medicinal products (Directive 2001/83/EC as amended) for the generic medicinal product Ciprofloxacine Kabi (ciprofloxacin hydrogen sulphate), from Fresenius Kabi. The procedure was initiated by the United Kingdom with a view to harmonise the summary of product characteristics across the European Union regarding the dosages used to treat complicated urinary tract infections.

A more detailed CHMP meeting report will be published shortly.

--ENDS--

European Medicines Agency: Committee for Medicinal Products for Human Use 26-28 June 2006

Adopted Reference Number: EMEA/243602/2006