While Sanofi's highly anticipated diet drug Acomplia (rimonabant) is now available in Germany as well as the U.K., summer has ended and fall arrived with still no word from Sanofi Aventis or the FDA on the fate of the diet pill in the United States.
We cannot help but wonder, however, whether the very low-key introduction of Acomplia in Germany may have been designed to address FDA concerns after the high-profile launch of the diet drug three months ago in the U.K.
When Acomplia was launched in the U.K. in June, a big-time press conference produced British newspaper headlines hailing it as a "Wonder Drug," a "Wonder Weight Loss Pill," a "Fat-Busting Drug" said to produce "Amazing Results," and the start of the "Obesity Drug Revolution."
These headlines have to have set off tremors at the FDA, where the worst fear of regulators is the likelihood of massive demand for this pill from overweight individuals -- including preteens and teens -- who do not fit the profile of the seriously obese and prediabetic patients for whom Acomplia is intended.
But there was no similar publicity blitz in Germany. Had we not hear from Acomplia Report readers that they are now able to purchase the drug in Germany pharmacies, we would not even know for sure that the product was available. Our emails to Sanofi's media relations office have gone unanswered.
Similarly, we have been unable to confirm with Sanofi that Acomplia is now available in Denmark, where Sanofi said it was planning to launch the diet drug immediately after the Danish regulators set the price on Sept. 15th.
Since the Danish Medicines Agency has published a price of 108.05 Euros (US$138.22) for a four-week supply of Acomplia -- considerably higher than the 80.32 Euro (US$102.60) price announced by Sanofi for Germany -- the drug may now be available in Denmark as well.
If any of our Danish readers have actually purchased Acomplia in Denmark, please email us when and where.
Ireland, Finland and Norway have been identified as other countries where Acomplia is expected to be available before the end of 2006.
But the timeline for action on Acomplia in the U.S. grew even more uncertain today with publication of a scathing report by the prestigious Institute of Medicine on the FDA's drug safety system.
Among other things, the IOM proposed limiting advertising on new drugs, more authority for the FDA to require post-market safety studies, and to fine safety offenders.
A number of concerns have been raised about Acomplia's side effects, and most observers believe the FDA will not act on Acomplia until safety issues have been considered by an independent FDA advisory panel.
But there is no sign such an advisory committee meeting will be held anytime soon.
An updated calendar of FDA advisory committee meetings was posted on September 21st, and the Endocronologic and Metabolic Drugs panel -- which would be the one to weigh-in on Acomplia -- has no meeting scheduled for that purpose from now through the end of the year.