After a knock-down at FDA on Tuesday, AstraZeneca ($AZN) got a leg up yesterday with the approval of its blood thinner Brilinta. It's been a long road, and the FDA nod isn't without its caveats. Analysts are divided on whether Brilinta will become a formidable competitor to the standard clotbuster Plavix, which goes off patent next year. But the U.K.-based drugmaker can finally launch the drug in the U.S.--and find out what happens.
Of course, there had been concerns that Brilinta might not win FDA's approval after the agency raised questions about differences in efficacy in North America. But the agency's questions about that appear to have been satisfied, and dispatched with a boxed warning about combining Brilinta with high-dose aspirin therapy.
That warning poses a challenge for AstraZeneca's marketing, Bernstein analyst Tim Anderson said, because high-dose aspirin is an "entrenched" therapy. The drugmaker will have to persuade doctors to change their protocols and combine Brilinta with low-dose aspirin instead. AZ can point to data showing that Brilinta/Brilique was better than Plavix at preventing heart attacks and death, at least in patients who did not take high-dose aspirin. But Anderson is skeptical, Bloomberg reports, saying that payers will have "ammunition to disadvantage Brilinta."
Not to mention the fact that Plavix goes off patent in the U.S. next year, so Brilinta will have to compete with low-cost generics. Plavix generics have already hampered the new drug's uptake in Europe, where it is sold under the brand name Brilique, as the New York Times points out.
Some other analysts were lukewarm on the approval, as the Wall Street Journal notes. Matrix called the label "less competitive" than the company would have liked. Jeffries called the FDA nod a "pyrrhic victory" and predicted a "slow U.S. launch." But MF Global said the OK should push market-watchers to upgrade AstraZeneca's stock.
Bottom line: AstraZeneca has something big to prove with the Brilinta launch. It's going to be a boots-on-the-ground effort. Doctors will have to be persuaded to change their behavior, and payers will have to be convinced to pay brand-name prices for Brilinta rather than fall back on the soon-to-be-less-expensive Plavix.
- get the release from FDA
- see the NYT piece
- read the Bloomberg news
- check out the WSJ analysis