PRESCRIRE'S RATINGS Our judgement is based on the therapeutic Translated from Rev Prescrire July 2011; 31 (333): 498 advance of the new product. It considers not only the inherent value of Onsenal°: marketing authorisation each product in terms of its risk-benefit balance, but also its advantages and withdrawn in the European Union disadvantages relative to existing products Company failed to supply required data available in France. Note that the relative value of new products can vary from one country to another.  An example representative of the In early 2011, the company had still drawbacks of the insufficiently not provided these data, because of BRAVO: The product is a major thera- demanding marketing authorisation slow enrolment in the trial. It therefore peutic advance in an area where previ- procedure. asked that marketing authorisation be ously no treatment was available. withdrawn (1,2). In late March 2011, European mar- This is an example representative of the keting authorisation for Onsenal° (cele- failings of current EU health policies: mar- A REAL ADVANCE: The product is an coxib; Pfizer) was withdrawn at the com- keting authorisation is increasingly grant- important therapeutic innovation but pany’s request (1,2). Onsenal° had been ed on the basis of insufficient data. Yet, has certain limitations. marketed in France since late 2010. even with the simplified procedure, com- This nonsteroidal anti-inflammatory panies often fail to fulfil their obligations. OFFERS AN ADVANTAGE: The prod- drug, a “selective” cox-2 inhibitor, was ©Prescrire uct has some value but does not fun- authorised in the European Union for damentally change the present thera- peutic practice. “the reduction of the number of adeno- a- Marketing authorisation is granted under “exceptional matous intestinal polyps in familial ade- circumstances” when epidemiological, scientific or ethical nomatous polyposis considerations mean that a drug cannot be fully evalua- ”, despite a negative ted (ref 4). POSSIBLY HELPFUL: The product has harm-benefit balance (2,3). The efficacy minimal additional value, and should celecoxib of in terms of colorectal can- Selected references from Prescrire’s literature not change prescribing habits except in cer prevention has not been demon- search. rare circumstances. 1- Commission européenne “Décision (...) retirant, strated, but its adverse effect profile is à la demande du titulaire, l’AMM du médicament particularly unfavourable and includes “Onsenal”” 24 March 2011 + “Annexe II-Onsenal” NOTHING NEW: The product may be a haemorrhage and cardiovascular disor- 28 July 2010: 6 pages in total. 2- EMA “Public statement on Onsenal (celecoxib)” new substance but is superfluous ders (3). Marketing authorisation had 1 April 2011: 2 pages. becau se it does not add to the clinical been granted in 2003 under “exception- 3- Prescrire Editorial Staff “Celecoxib: colorectal possibilities offered by previous products al circumstances” (a), with the company cancer: no preventive benefit” Prescrire Int 2006; 15 available. In most cases it concerns a (81): 13-15. me-too product. obligated to continue the assessment in 4- Prescrire Rédaction “Dérogations à l’AMM “clas- to provide further data sique”” Rev Prescrire 2008; 28 (299): 696-701. order “ ” (1,2). JUDGEMENT RESERVED: The edi- tors postpone their rating until better data and a more thorough evaluation of the drug are available.

NOT ACCEPTABLE: Product without evident benefit but with potential or real disadvantages.

INTERNATIONAL A drug's NONPROPRIETARY real name INN NAME Quality of information Translated from Rev Prescrire September 2011; 31 (335): 662 from pharmaceutical COMMON STEM -conazole companies The international nonproprietary The INN of another drug In response to our systematic requests names (INN) of antifungal drugs derived derived from , , from miconazole end in -conazole (1,2). does not include the key stem -conazole, Company provided detailed information On 21 June 2011 there were 42 sub- but simply the letters “onazole” (1). including unpublished data and packaging stances of this type on the World Health ©Prescrire items. Organization (WHO) list of INNs (3). Thir- teen of them are marketed in France, for Company provided information limited to topical application (cutaneous, vaginal, Selected references from Prescrire’s literature administrative and published data. etc.), oral administration or injection, search. flu- 1- WHO “The use of stems in the selection of INN. namely , , WHO/EMP/QSM/2009.3”: 75-76. conazole, , , keto- 2- Company provided minimal information, Prescrire Rédaction “le suffixe du mois -conazole” mainly administrative data. conazole, miconazole, omoconazole, oxi- Rev Prescrire 1991; 11 (112): 520. conazole 3- “Substances names ending with conazole”. , , , Mednet.who.int accessed on 21 June 2011: , and . 2 pages. Company provided no information.

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