Global Insight Perspective
Sanofi-Aventis’ potential blockbuster obesity drug Acomplia has seen its first major approval, in the European Union (EU).
The drug will be rolled out across six countries beginning from July. The EU approval has arrived earlier than in the U.S., where Sanofi-Aventis is still waiting for a sign, following an approvable letter in February.
The drug is expected to sell well during its first full year on the market, with results available from 2007. Further testing will determine whether Sanofi plans to re-file the drug for approval as a smoking-cessation treatment in the future, after having already been turned down once.
France’s leading pharmaceutical company, Sanofi-Aventis, has seen its star product candidate, Acomplia (rimonabant), approved by the European Commission (EC) as a treatment for obese or overweight patients with associated risk factors, including type 2 diabetes or dyslipidaemia. The regulatory nod from the EC has come less than two months after a positive recommendation for approval from the European Medicines Agency (EMEA, see France: 1 May 2006: Sanofi-Aventis Clinches EMEA Recommendation for Acomplia in Weight-Loss Indication Only), and will allow Acomplia to be sold in all 25 countries of the European Union (EU), as well as in non-EU state Norway. The United Kingdom will be the first member state to launch the drug in July, followed by Denmark, Ireland, Germany, Finland and Norway during the second half of 2006.
EU approval for 20-mg once-daily Acomplia tablets has not only occurred some months earlier than expected by Sanofi-Aventis; it has also arrived ahead of marketing approval in the U.S. There, Sanofi has received an approvable letter over the eventual approval of Acomplia as a weight-loss drug, but has also received a non-approvable letter for marketing the drug as a smoking-cessation aid (see France: 20 February 2006: U.S. FDA Deals Blow to Sanofi-Aventis with Approval Delay for Weight-Loss Drug). The EMEA also declined to recommend Acomplia in this second indication, leading to the drug's current approval as a prescription for weight-loss only. Sanofi-Aventis has thus far kept quiet on its failure to clinch approval for Acomplia as a smoking-cessation drug.
Outlook and Implications
Over a year after Sanofi-Aventis first filed Acomplia with the U.S. and EU regulatory authorities (see France: 16 May 2005: Sanofi-Aventis Files for Acomplia Approval in Europe, US), its plans for bringing the drug to market have been subjected to several important changes. Approval in the U.S. market, which had been forecast originally for the first half of 2006, has now been superseded by approval in Europe, and though the chances of the drug’s approval in the U.S. remain good, there are still potential delays ahead. Sanofi-Aventis is currently embroiled in a drug-safety scandal with the FDA over another product, antibiotic Ketek (telithromycin, see France: 9 June 2006:Sanofi-Aventis Halts Paediatric Ketek Trials, as OptiClik Investigation Looms). The Ketek controversy began at the start of 2006, when reports emerged of a possible link between the drug and the rapid onset of liver failure. In May, several U.S. Senators raised the issue with the FDA, concerned with the FDA’s approval of Ketek for marketing without informing its advisory committee of potential flaws surrounding the data from the trial, on which the approval had been based.
The Ketek controversy is a completely separate issue to Acomplia, which has proved exceptionally safe and well-tolerated. The fact remains, however, that the FDA may now choose to exercise caution in approving a new treatment from Sanofi-Aventis, particularly a first-in-class drug, while it is under scrutiny by government officials over its existing approval procedures.
When first presenting trial results for Acomplia last year, Sanofi made much of the compound’s ability to interfere with the body's chemical reward system and proceeded to develop the drug both as an obesity treatment and as a smoking-cessation aid. There was even speculation as to whether the drug could eventually be developed to treat other forms of addiction, including dependency on alcohol and drugs. However, Acomplia’s status as a first-in-class drug (a selective cannabinoid type 1 (CB1) blocker), its rejection for the smoking-treatment indication by both the U.S. and European authorities is not unexpected, since the drug was always going to be closely scrutinised by regulatory approval agencies. Following Acomplia’s first major approval by the European Commission, Sanofi-Aventis has remained silent over its future plans regarding this potential-blockbuster second indication. Previously, however, the company acknowledged that there are ongoing large-scale studies of up to 22,000 volunteers currently being conducted on Acomplia, and these will give Sanofi the opportunity to file for additional indications in the future.