European Medicines Agency: Committee for Medicinal Products for Human Use 20-23 March 2006

Initial marketing authorisation applications

The Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions on initial marketing authorisation applications for:

• Ganfort (bimatoprost/timolol), Allergan Pharmaceuticals Ireland. Ganfort is an eye-drop solution, intended for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. EMEA review began on 18 May 2005 with an active review time of 196 days.
• Zostavax (herpes zoster vaccine), Sanofi Pasteur MSD. Zostavax is a vaccine intended for the prevention of herpes zoster (shingles) and herpes zoster related postherpetic neuralgia (PHN). EMEA review began on 15 June 2005 with an active review time of 202 days.

Re-examination procedure concluded
Following the re-examination of the negative opinion adopted on 15 December 2005, the Committee confirmed its previous position, recommending not to grant a marketing authorisation for Zelnorm (tegaserod), from Novartis Europharm Limited for the repeated symptomatic short-term treatment of irritable bowel syndrome in women whose predominant bowel habit is constipation.

A question and answer document explaining the grounds for the negative opinion has been published and can be found here.

Extensions of indications and other recommendations

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

• Emend (aprepitant), from Merck Sharp & Dohme, to add prevention of post-operative nausea and vomiting. Emend was first authorised in the European Union on 11 November 2003. It is currently approved for prevention of nausea and vomiting in chemotherapy.
• Keppra (levetiracetam), from UCB S.A., to add treatment of myoclonic seizures in patients with juvenile myoclonic epilepsy. Keppra was first authorised in the European Union on 29 September 2000 and is currently approved for adjunctive therapy in the treatment of partial onset seizures in patients with epilepsy.
• Taxotere (docetaxel), from Aventis Pharma S.A., to add the treatment of metastatic gastric adenocarcinoma in combination with cisplatin and 5-fluorouracil. Taxotere was first authorised in the European Union on 27 November 1995. It is currently approved for use in the treatment of breast cancer, non-small cell lung cancer and prostate cancer.

Summaries of opinions for all these products are available and can be found here.

Review procedure started

The Committee started an arbitration procedure for three generic doxazosin-containing medicines: Cardoreg from Pharmcom Oy, Doxagamma from Generics UK limited, Doxastad from Stada Arzneimittel. The procedure under Article 29 of the Community code on human medicinal products (Directive 83/2001/EC as amended) was initiated on the request of the United Kingdom because of potential differences in the release profile between the reference product and the generic versions. 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.

Review procedure concluded

The Committee finalised a referral procedure for atorvastatin-containing medicinal products (Sortis and other associated names) recommending the grant of an extension of indication to patients who have a high risk for a first cardiovascular event. The procedure was initiated by Spain under Article 6(12) of Commission Regulation (EC) No 1084/2003 following an application submitted by Parke- Davis GmbH to extend the indication to the prevention of cardiovascular events in patients with multiple risk factors. The CHMP was asked to look at the issue because Member States had different opinions with regard to the extent of the patient population likely to benefit from atorvastatin therapy in this clinical setting, especially in view of the lack of established benefit in women observed in the clinical trials.

A more detailed CHMP meeting report will be published shortly.

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