Diet drug Acomplia users in Germany got bad news on June 20th when a Berlin court upheld a German regulatory body's decision classifying rimonabant as a "lifestyle" drug not eligible for reimbursement by German state health insurers.

The court upheld a decision by Germany's Joint Federal Committee (G-BA) last October that Acomplia should be placed on the country's negative list which specifies those products which are not reimbursed.

A month's supply of Acomplia in Germany runs about 100 Euros (U.S. $130). Nine out of 10 Germans are charged only a co-pay for drugs covered by state insurance, and in the case of Acomplia, the co-pay would have been about $10.

Today's court decision rejecting an appeal by Sanofi-Aventis means patients in Germany will have to pay for the entire cost of Acomplia out of their own pocket.

Almost 50,000 Germans were prescribed Acomplia between June and November of last year, according to documents released last week in the U.S., making Germany the biggest market thus far for the medicine.

The decision was the second piece of bad news in a week for Sanofi-Aventis, which was rocked by an FDA advisory panel recommendation that rimonabant not be approved for sale in the United States because of safety concerns.

Acomplia is the first in a new class of drugs that works by blocking CB-1 receptors, and the drug has been linked to an increased incidence of depression and "suicidality."

The European Medicines Agency, which approved sale of Acomplia in the European Union more than a year ago, is reviewing the FDA committee's decision and new data that was presented at the U.S. meeting.

Source: http://www.acompliareport.com...;