The early returns are in and the winner is ……

The early returns are in and the winner is ……

While it’s still early it looks as though Actos is the big winner as the replacement for Avandia. According to the most recent prescription data new prescriptions for Actos increased 56% last week. Also benefiting from the Avandia demise, new and total prescriptions of Avandia were down 21.3% and 16.4% worldwide respectively, were Januvia and Byetta, both drugs seeing an increase in new prescriptions.

The switch to Actos is not unexpected, like Avandia Actos is part of the TZD class of drugs and until the report came out on Avandia many considered the drugs nearly mirror images of each other. However this move to Actos could backfire should Actos be hit with the same concerns surrounding Avandia. Some may recall that when the ADOPT data was released we learned of a new Avandia side effect, an increase in bone fractures. At the time Takeda, who makes Actos, said they did not see the same effect in Actos patients. This position was later reversed as researchers found that Actos users also had a higher incidence of bone fractures.

Back in February, the FDA approved safety labeling revisions for Actos that include new data regarding the risk for macrovascular disease. Some believe that Actos is just as dangerous as Avandia, while others contend the drug is safer than Avandia. Based on the fact that both drugs are part of the same class it is up to the FDA to clarify the situation. This places an even greater burden on the agency. Is it possible to issue a “black-box” warning for Avandia and not Actos? Will the agency require more data or trials for Actos? What happens if the FDA decides to issue “black-box” warning for both Avandia and Actos?

It is likely we’ll get a glimpse of what’s in store for both drugs when a Congressional committee holds a hearing this Wednesday on Avandia. In what certainly will be a circus like event this hearing should have more twists and turns than the afternoon soaps. The question is will the hearings actually accomplish anything or will it be more hot air from a bunch of politicians looking for attention and votes.

Given that the Avandia situation comes on the heels of the Vioxx situation, Diabetic Investor sees the FDA coming down hard on the drug. We also believe the agency won’t take any chances with Actos and will call for even more label changes. This then places the burden back to the physician who then must decide if another switch in therapies is warranted or risk keeping their patients on Actos. And around and around we go.

David Kliff
Diabetic Investor
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