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Sanofi's wonder drug in limbo after regulator's rejection

Published on 23/02/06 at 10:37am

The future of Sanofi-Aventis' Acomplia is in serious doubt after regulators demanded more data for its use in weight loss, and rejected it outright as a treatment to help smokers kick their habit.

Acomplia (rimonabant) is the first in a new class called cannabinoid receptor antagonists and had been hailed as a wonder drug, promising to help patients quit smoking and lose weight, but the FDA's reservations could scupper the treatment.

Analysts had predicted peak annual sales as high as $3.7 billion for Acomplia, and Sanofi-Aventis will have a major hole in its portfolio for future growth if the drug fails to reach the market or receives restricted approval.

The regulator has not issued any statement regarding the rulings from two separate committees, but analysts predict that the number of patients dropping out of clinical trials, and doubts about possible depression side-effects are behind the decision.

In the latest data released by the company, discontinuation rates in patients taking 20mg of the drug were 12.8% compared to those on placebo at 7.2%, a figure likely to be of concern to FDA experts.

Investigators found 'depressed mood order' in 5.2% of patients on the drug, a side-effect which proved to be the biggest single reason for patients to drop out of the trial, followed by anxiety and nausea.

Acomplia has been issued with a 'non-approvable' letter for its indication in smoking cessation - meaning it is almost certain to never gain a licence for this, while receiving an approvable letter for obesity - signalling that further data is needed to convince the FDAs experts.

Sanofi-Aventis maintains the drug is a breakthrough in treating obesity and cardiovascular disease, with its latest two-year trial demonstrating good results.

The trial showed that patients not only lost weight and reduced their waist circumference (a good indicator of obesity risk) but also positive effects in cholesterol lowering, triglycerides, fasting insulin and insulin sensitivity above and beyond the effect of weight loss alone.

The company said patients benefited from the two-year treatment course, but would have to overcome FDA safety doubts before it could promote Acomplia's longer-term benefits.

Sanofi-Aventis filed Acomplia more or less simultaneously in Europe and the US in June last year, and is expected to hear the judgement of the European medicines agency shortly.

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