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    EMEA CMPH Use Adopts 5 Positive Opinions Recommending The Granting Of A Marketing Authorisation For The Following Medicinal Products

-- Aerinaze (desloratadine 2.5 mg/pseudoephedrine sulphate 120 mg), from Schering-Plough Europe, for the symptomatic treatment of seasonal allergic rhinitis, accompanied by nasal congestion. EMEA review began on 26 July 2006 with an active review time of 196 days.

-- Increlex (mecasermin), from Tercica Europe Ltd, for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor1 deficiency or with growth hormone (GH) gene deletion who have developed neutralising antibodies to GH. Increlex is the 39th orphan medicinal product to receive a positive opinion. The CHMP recommended the granting of a marketing authorisation under exceptional circumstances. Such authorisations are permissible for medicinal products for which the applicant can demonstrate that comprehensive data cannot be provided, for example because of the rarity of the condition, as long as it can be demonstrated on a regular basis that the benefits outweigh the risks. EMEA review began on 28 December 2005 with an active review time of 208 days.

-- Mircera (methoxy polyethylene glycol-epoetin beta), from Roche Registration Ltd, for the treatment of anaemia associated with chronic kidney disease. EMEA review began on 24 May 2006 with an active review time of 176 days.

-- Optimark (gadoversetamide), from Tyco Healthcare Deutschland GmbH, for use in magnetic resonance imaging. EMEA review began on 24 May 2006 with an active review time of 196 days.

-- Orlistat GSK (orlistat), from Glaxo Group Ltd trading as GlaxoSmithKline, for the treatment of obese patients and overweight patients with associated risk factors. The application for marketing authorisation for Orlistat GSK was made as an 'informed consent' application to Xenical, from Roche Registration Ltd. This type of application requires that reference be made to an authorised medicinal product and that the marketing authorisation holder of this reference product give consent to the use of the dossier in the application procedure. EMEA review began on 25 March 2007 with an active review time of 60 days.

Negative opinions

The CHMP adopted a negative opinion recommending the refusal of a marketing authorisation for Vectibix (panitumumab), from Amgen Europe B.V., intended for the treatment of metastatic carcinoma of the colon or rectum after failure of oxaliplatin- and/or irinotecan- containing chemotherapy regimens.

A separate question-and-answer document explaining the grounds for the negative opinion for Vectibix
Extensions of indication

The CHMP gave positive opinions for applications for extensions of indication, adding new treatment options for the following previously approved medicines:

-- Forsteo
(teriparatide), from Eli Lilly Nederland B.V., to extend the indication to include treatment of osteoporosis in men. Furthermore, the indication has been revised to osteoporosis in postmenopausal women "at increased risk of fracture" and to include a statement on reduction in non-vertebral fractures in women. Forsteo is currently authorised for the treatment of established osteoporosis in postmenopausal women.

-- Plavix (clopidogrel), from Sanofi Pharma Bristol Myers Squibb SNC, and Iscover (clopidogrel), from Bristol-Myers Squibb Pharma EEIG, to clarify its indication (in combination with acetylsalicylic acid) in the prevention of atherothrombotic events in patients suffering from non-ST segment elevation acute coronary syndromes, to include patients to be managed with a stent following a percutaneous coronary intervention procedure. Plavix is currently authorised for prevention of atherothrombotic events in patients suffering from myocardial infarction, ischaemic stroke or established peripheral arterial disease and, in combination with acetylsalicylic acid, for the treatment of patients suffering from non-ST segment elevation acute coronary syndromes (unstable angina or non-Q-wave myocardial infarction) and of patients suffering from ST segment elevation acute myocardial infarction who are eligible for thrombolytic therapy.

Changes to contraindications

The CHMP recommended the removal of the contraindication regarding the concurrent administration of Sustiva (efavirenz), from Bristol Myers Squibb Pharma EEIG, and Stocrin (efavirenz), from Merck Sharp & Dohme, with voriconazole. The recommendation to remove the contraindication was made in the context of dose adjustments agreed by the CHMP. Sustiva and Stocrin are currently authorised for antiviral combination treatment of HIV-1 infected patients.

Summaries of opinions for all mentioned products, including their full indication, can be found here http://www.emea.europa.eu/htms/human/opinion/opinion.htm.

Referral procedures concluded

Finalising a review of the safety and efficacy of bicalutamide 150 mg-containing medicinal products in the treatment of locally advanced prostate cancer, the CHMP concluded that the benefits of these products outweigh their risks, but only in those patients who are at high risk of their disease getting worse.

This referral procedure was initiated by Belgium because of efficacy and safety concerns, in particular concerns over heart problems, regarding the use of the medicinal product in the treatment of early prostate cancer.

The legal basis for this procedure was Article 31 of the Community code on human medicinal products (Directive 2001/83/EC as amended). A separate question and answer document with more detailed information on the referral is available here
The CHMP finalised a referral procedure for Vantas 50 mg implant (histrelin acetate), from Valera Pharmaceuticals Ltd, Ireland, concluding that the benefits of Vantas outweigh its risks in the palliative treatment of advanced prostate cancer. The procedure was initiated under Article 29 of Directive 2001/83/EC as amended because of disagreement between the Member States in the context of the mutual recognition procedure regarding the safety and efficacy of the medicinal product.

Referral procedures startedbr>
The CHMP started a review of systemic formulation of nimesulide-containing medicinal products due to concerns over serious liver problems. This follows the suspension of the marketing authorisations in Ireland for all nimesulide-containing products by the Irish Medicines Board on 15 May 2007.

Products containing nimesulide are approved in a number of Member States for the treatment of acute (short-term) pain, symptomatic treatment of painful osteoarthritis and primary dysmenorrhea (period pains).

The CHMP is now looking at the available scientific data on nimesulide to reach a scientific opinion in July 2007 on whether the marketing authorisations for nimesulide should be maintained, changed, suspended or revoked in the Member States where it is marketed. The review was initiated under Article 107 (2) of Directive 2001/83/EC as amended.

The CHMP started a referral for Belara and Balanca (30 micrograms ethinyl estradiol + 2 mg chlormadinone acetate), from GrĂ¼nenthal GmbH, because of differences among Member States on whether the indication of these two products should be extended to include the treatment of women suffering from moderate acne.

Belara and Balanca are currently authorised in a number of Member States as oral contraceptives.

The referral procedure was initiated under Article 6(12) of Commission Regulation (EC) No 1084/2003. This type of procedure is initiated in cases where Member States disagree on a variation to the marketing authorisation of a product under the mutual recognition procedure.

The CHMP started harmonisation referrals for Efexor and associated names (venlafaxine) and Efexor Deport and associated names (venlafaxine), both from Wyeth, on the request of the European Commission. The procedure was initiated under Article 30 of the Community code on human medicinal products (Directive 2001/83/EC as amended). This type of procedure is initiated with a view to harmonising product information for medicinal products authorised at Member State level.

A more detailed CHMP meeting report will be published shortly.

http://www.emea.europa.eu

Publication Date: 2007-05-29 14:00

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