Highly anticipated diet drug Acomplia (rimonabant) went on sale in Sweden on Nov. 10th, but the far-more exciting news for manufacturer Sanofi-Aventis was that the cost of the weight-loss pill will be reimbursable by Sweden's public health service.

The decision by Sweden's Pharmaceutical Benefits Board brings to three the number of small European countries that now have decided to cover Acomplia for obese and overweight patients with associated health risks such as diabetes.

The health services in Denmark and Ireland have also agreed to reimburse patients for the drug, but in Germany -- the European Union's largest market -- the regulatory body that decides which medicines will be covered by insurers classified Acomplia as a "lifestyle" drug not eligible for reimbursement.

Sanofi has said it will appeal the German decision if it is upheld by the German Health Ministry.

With the addition of Sweden, Acomplia is now on sale in eight European Union countries as well as in Argentina. It has been approved for sale in Mexico, but will not be available there until the start of 2007.

Meanwhile, analysts continue to hope for some word from Acomplia as to how the U.S. Food and Drug Administration intends to treat the full response Sanofi provided on Oct. 26 to the agency's request for additional information.

Under FDA guidelines, the agency was supposed to notify Sanofi by the end of this week as to whether it would put Acomplia -- which has been stalled since February -- back on a two-month track for a decision, or whether it would take an additional six months to weight approval of the diet pill.

Most FDA observers believe the agency will have one of its advisory panels hold an open hearing to air the issues surrounding Acomplia before acting -- a decision that would automatically give Sanofi's rimonabant resubmission a Class 2 status meaning a six-month timeline for action.

source from: http://www.acompliareport.com.