Takeda is kicking off a direct-to-consumer campaign for type 2 diabetes pill Actos today, as the FDA considers whether Actos' direct rival, the GlaxoSmithKline drug Avandia, can remain on the market.
The Takeda campaign comes a day after a split vote was seen on Avandia by an FDA advisory panel, but one in which the panel came down on the side of keeping the GSK diabetes drug on the market but with additional warnings attached to the product. Although it could follow the 12 advisors (out of 33) who voted for withdrawal, the agency usually heeds panels' consensus view. That would mean that the diabetes market will continue to have two thiazolidinediones (TZDs), the class of drugs to which Actos and Avandia belong, although doctors would be far less likely to prescribe Avandia.
Takeda, in its response after the meeting and in an ad breaking today, is underscoring Actos' safety profile and stressing that Avandia's CV issues are not a class effect. The full-page promotion in today's New York Times
notes, “Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke.” The ad, by AbelsonTaylor, will appear in 154 publications over the next few weeks, hitting 85 local markets, plus several national magazines, Takeda told MM&M
. At this time, there is no TV component, but some online elements may be included, a spokesperson added. The straight-talking creative also appears on the landing page of Actos.com.
“Takeda has consistently emphasized the importance of physician education and patient safety in communications involving Actos, and has prioritized communicating the appropriate use of Actos in patients with type 2 diabetes,” notes a company statement on the campaign. “Healthcare providers must make prescribing decisions for each individual patient by weighing the risks and benefits of such a change. We encourage anyone with questions to talk to their healthcare provider before making any changes to their type 2 diabetes treatment regimens or goals.”
This is not the first time Takeda has reached out with new Actos messaging in the wake of negative publicity around the oral anti-diabetes market. In 2007, after the FDA first reviewed Avandia in light of its cardiovascular safety signal, overall sales of insulin sensitizers fell during the first half of the year, suggesting that the Avandia controversy was scaring diabetes patients away from the oral meds. Takeda responded with a national print ad campaign for Actos. That effort, also by AbelsonTaylor, was very similar in reach and tone
, seeking to promote clarity and get diabetes patients to talk to their physicians.
GSK noted, after yesterday's review, that results from six clinical trials, released since 2007, “show that Avandia does not increase the overall risk of heart attack, stroke or death. As a result, we believe that when used in the appropriate patient and in accordance with labeling, Avandia is a safe and effective treatment option for type 2 diabetes.”
Between 2007 and 2009, Avandia's US sales eroded 63% to $408 million, according to SDI, while Actos' increased 14% to $2.5 billion. Through May of this year, Avandia posted US sales of $145 million, an 18% decline vs. the first five months of 2009, while Actos' increased 3.5% to $1.1 billion. With new warnings likely, Avandia sales seem destined to fall further.
Sanford Bernstein analyst Tim Anderson, in a research note issued after yesterday's panel vote, pointed out that the Avandia franchise, which also includes diabetes combo drugs Avandaryl and Avandamet, has lost nearly two-thirds of its sales globally since 2007 and that Avandia, in total, is likely to only account for about 2% of total GSK sales this year. “That contribution will diminish moving forward,” he wrote.
Even if the FDA votes to keep Avandia on the US market today, Avandia is not fully out of the woods. Global regulatory bodies have yet to do their own safety reviews, including a European review by the EMEA scheduled for July 19-22. Notes Anderson: “It is possible that Avandia could still face withdrawal in certain ex-US markets, but the odds seem better now with the US recommendation to stay on the market in hand."