CMG Croma Grp

The European Medicines Agency, or EMA, Friday said the Committee for Medicinal Products for Human Use, or CHMP, adopted positive opinions recommending the granting of marketing authorisations for a number of new medicines.

MAIN FACTS:

-Adopted positive opinions recommending the granting of marketing authorisations for:

*Eliquis (apixaban), from Bristol-Myers Squibb/Pfizer EEIG.

*Yellox (bromfenac), from Croma-Pharma GmbH.

*Zoely and IOA (nomegestrol acetate/estradiol), from Merck Serono Europe Ltd and N.V. Organon.

-Committee gave also a positive opinion for Cinryze (C1 inhibitor, human), an orphan medicine from ViroPharma SPRL; However, the CHMP noted that ViroPharma is considered the same applicant as Sanquin, which holds marketing authorisations in some European Union Member States for a medicine with the same composition and pharmaceutical form and overlapping indications with Cinryze; This may preclude the granting of a marketing authorisation for Cinryze.

-Committee adopted positive opinions for applications for extensions of therapeutic indications, adding new treatment options for medicines that are already authorised in the E.U., for:

*Herceptin (trastuzumab), from Roche Registration Ltd.

*Lucentis (ranibizumab), from Novartis Europharm Ltd.

*Remicade (infliximab), from Janssen Biologics B.V.

*Revatio (sildenafil), an orphan medicine from Pfizer Ltd.

-Committee adopted a negative opinion for Vectibix (panitumumab), from Amgen Europe B.V..

-Committee has been informed by Genzyme Europe B.V., the marketing authorisation holder for Thyrogen (thyrotropin alfa), that due to a manufacturing issue there will be a supply shortage of this medicine until July 2011; Genzyme will only be able to supply Thyrogen to meet approximately 45% of E.U. demand through to July 2011.

-Committee completed an arbitration procedure initiated because of disagreement among E.U. Member States regarding the authorisation of the generic medicine Canazole (Clotrimazole Cream 1%), from Pinewood Laboratories Ltd.

-Committee recommended the harmonisation of the prescribing information for Arimidex (anastrozole), from AstraZeneca.

-Committee has begun looking at the benefit-risk balance of the antidiabetic pioglitazone-containing medicines, from Takeda Global Research and Development Centre (Europe) Ltd.

-Committee has begun looking at the benefit-risk balance of the orphan medicine Revlimid (lenalidomide), from Celgene Europe Ltd.

-Committee has begun a review of Vivaglobin and associated names (human normal immunoglobin for subcutaneous use), from CSL Behring, following reports indicating that Vivaglobin may be associated with thromboembolic events.

-Committee has begun looking at the results of a good clinical practice, or GCP, inspection indicating that the clinical studies performed as part of the marketing authorisation applications for Novosis Goserelin, Goserelin cell pharm, Novimp and associated names (goserelin), have not been GCP compliant.

-By Jana Weigand, Dow Jones Newswires; 44-20-7842-9314; jana.weigand@dowjones.com

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