Dabigatran 150-mg was exclusively approved by the FDA to reduce stroke and systemic embolism in nonvalvular atrial fibrillation, despite the 110-mg dose also demonstrating effectiveness.
Why did the FDA approve the 150-mg dose of dabigatran but not the 110-mg dose for reducing stroke and systemic embolism in patients with nonvalvular atrial fibrillation?
The FDA approved only the 150-mg dose of dabigatran for stroke prevention in nonvalvular atrial fibrillation, determining that patients should receive the higher dose over the effective 110-mg alternative.
Absolute Event Rate: 0% vs 0%
Last fall, the FDA approved dabigatran, in a 150-mg dose only, for reducing risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. A 110-mg regimen was also effective, but the agency believes that patients should receive the higher dose.
Beasley et al. (Wed,) reported a other. Dabigatran 150-mg was exclusively approved by the FDA to reduce stroke and systemic embolism in nonvalvular atrial fibrillation, despite the 110-mg dose also demonstrating effectiveness.