Just how much danger does Plavix face from the new Effient approval? Depends on who's talking. Theoretically, the new Eli Lilly/Daiichi Sankyo blood thinner could significantly eat into the Bristol-Myers Squibb med's market. The new FDA approval--for angioplasty patients--was based on a head-to-head trial against Plavix, after all.
But then there's the "black box" warning attendant on Effient's premiere. FDA is requiring the drug's makers to alert doctors and patients to an increased risk of fatal bleeding. Plavix doesn't carry the same cautionary language. And the warning is affecting pharma watchers' opinion of the drug. Tony Butler, an analyst at Barclays Capital in New York, told Bloomberg that the strict warning may affect his estimate of $1.5 billion in global sales.
And there's the fact that Effient's approved use will be in angioplasty patients, which amounts to "a fraction of the Plavix market," Matthew Herper at Forbes points out. A limited FDA OK doesn't mean that Effient can't be prescribed for any number of blood-thinner uses. Eli Lilly may not be able to overtly push the new drug for those indications, but that doesn't meant it won't be adopted.
Doctors told Forbes, however, that off-label uptake is likely to be small. "[T]he interventionalists love it," one said, but other cardiologists may not. Plus, as another doctor pointed out, Plavix has been around for years now, and so its safety profile is well known. "I do not see Effient supplanting Plavix for most patients," William Boden, a professor at the University of Buffalo, told Herper. Insurers may not be willing to pay for Effient for off-label use, either, Pharma Marketer points out. We'll all have to wait and see how the numbers come in.