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FDA pushed back the expected approval of this would-be blockbuster by giving manufacturer Sanofi-Aventis one ?approvable? letter and one non-approval. Analysts say the drug?s success depends on approval for more indications, and delay could give advantage to a competitor in the smoking-cessation category.
Despite a surprise setback, Sanofi-Aventis still hopes to launch its eagerly awaited Acomplia (rimonabant) in the United States during the second half of 2006, company executives announced in an earnings call Friday.
The announcement came a week after news that the Food and Drug Administration had delayed the approval of rimonabant for weight loss until certain conditions were met, and it issued a “non-approvable" letter for the drug in a second indication: smoking cessation.
The French company is keeping the details close to its vest, but it did reveal that FDA’s Metabolism and Endocrinology division did not ask for any new trials in order to gain approval for the weight-loss indication-but that new trials would be required before the drug could be approved for smoking cessation.
Industry analysts are still sorting out what this delay might mean, especially considering that drugs accounting for 40 percent of the company’s revenues will go off patent in the next five years.
“It’s a little disappointing,” said Morningstar analyst, Tom D’Amore. “But there’s still a long road ahead.”
D’Amore added that the “approvable” letter for obesity shows that there are no major problems or disqualifying side effects.
But Amit Roy, Citigroup analyst, expressed skepticism about Acomplia in a Feb. 23 report. Roy cited concerns over psychiatric side-effects in the obesity trial published in the Feb. 17 issue of the Journal of the American Medical Association.
On the smoking side, Bear Stearns analyst Alexandra Hauber wrote in a Feb. 20 report that questions about the drug’s effectiveness seem unlikely.
“It is difficult to say whether this points to a serious ‘absolute’ safety concern (regardless of clinical benefit), or the FDA is unhappy about the risk/benefit profile of Acomplia in smoking cessation,” Hauber wrote.
On the other hand, Wood Mackenzie senior analyst Martyn Link said the delayed weight-loss approval might not be such a bad turn of events.
“It may not be as negative as some people are thinking,” he said, noting the example of Ambien CR, which had a delayed approval, but debuted with a stronger label as a result.
Link added that other companies developing drugs to help people lose weight or quit smoking would pay special attention to the regulatory back-and-forth about Acomplia. This is especially true for any company working on compounds targeting the cannabinoid type-1 receptor, since Acomplia is the first drug in that class.
One potential beneficiary of Acomplia’s delayed entry into the anti-smoking arena is Pfizer, Link said. The company’s smoking-cessation drug Champix (varenicline) now might reach the market before Acomplia is approved for this secondary indication.
Acomplia has been hailed as a potential blockbuster, partly on the strength of its usefulness in multiple indications. But in order to live up to that potential, says Hauber, it needs to win approval for additional indications, particularly diabetes treatment and cardiovascular risk prevention.
Link agreed, noting that approval for weight-loss could serve as a platform to help Sanofi-Aventis launch Acomplia as a widely prescribed drug down the road.
“Post-marketing studies will be essential to get the large sales Sanofi-Aventis will be looking for,” he said.
If the drug is approved for obesity in 2006 and diabetes in 2007, sales could approach $892 million by 2010, according to Wood Mackenzie’s March 2006 Productview.