The Paris-based pharmaceutical company resubmitted on Oct. 26 a complete response to the conditional approval granted by the Food and Drug Administration in February.
The world's second biggest drug maker measured by prescription sales said the FDA considered Sanofi's resubmission to be a so-called "class two" response, which requires around six months to review.
If the regulator had opted to consider the resubmission as a "class one" response, which requires only a two-month review, Acomplia would have received a final verdict by Dec. 26, 2006.
Navid Malik, an analyst with London-based brokerage Collins Stewart, said the news was unsurprising, as several analysts had already begun questioning earlier forecasts by Sanofi management that a U.S. launch would be possible by the end of 2006.
A company spokeswoman declined to comment on the nature of the FDA's review, or on when Sanofi-Aventis plans to launch the drug in the U.S.
Malik noted that the FDA's six-month review is likely to focus on Acomplia's side-effects, such as nausea and depressed mood, which were also highlighted in a study presented earlier this week.
"It can't be labeling, because it wouldn't take so long. It obviously has to do with the side effects profile."
The study, which was presented Tuesday at an international diabetes congress in South Africa, showed Acomplia controls blood sugar and body weight in diabetic patients, boosting its potential to be used beyond obesity treatment.
Vontobel analyst Karl-Heinz Koch said he expects Sanofi-Aventis to reposition the drug, aiming to sell it for the treatment of diabetes.
Acomplia is approved in Europe for the treatment of obese or overweight patients and is sold in the U.K., Germany, Denmark, Sweden, Finland, Norway, Ireland, Argentina and Austria.
No comments:
Post a Comment