LONDON (Reuters) - AstraZeneca Plc has no plans to run a clinical trial to confirm the reasons behind a discrepancy between the performance of its newly approved heart drug Brilinta in North America and other parts of the world.
Some analysts have speculated such a move might make commercial sense, in order to strengthen the image of the brand, even though the company has not been asked to do so by regulators.
But Alex Gold, executive director of clinical development for Brilinta, said the Anglo-Swedish company was standing by existing data from the large 18,000-patient global study, known as PLATO, that formed the basis of Brilinta's submission to authorities around the world.
"We do not have a plan to do a confirmatory study in patients with acute coronary syndrome and the reason for that is that the PLATO trial was a state-of-the-art, real-world trial designed by experts in the field," he told Reuters.
AstraZeneca shares gained 3 percent on Thursday on relief over Brilinta's U.S. approval.
Many investors previously had serious doubts about its approval in the world's biggest market, as U.S. patients taking the drug did worse than those on Plavix in the PLATO study.
The reason appears to be because Brilinta interacts adversely with aspirin, which is typically given in much higher doses to U.S. heart patients -- a hypothesis the FDA accepted by warning Brilinta should only be used with low-dose aspirin.
Since high-dose aspirin is widely used by U.S. doctors, AstraZeneca faces a challenge in persuading them to change their approach when using Brilinta.
But Gold believes this is achievable, since he said there was no evidence that giving high-dose aspirin conferred any additional benefit over sticking to 75 to 100 milligrams per day.
(Reporting by Ben Hirschler; Editing by David Holmes)