The U.S. Food and Drug Administration today granted accelerated approval to idarucizumab for use in patients who are taking the anticoagulant dabigatran during emergency situations when there is a need to reverse dabigatran’s blood-thinning effects.
The anticoagulant effects of dabigatran are important and life-saving for some patients, but there are situations where reversal of the drug’s effects is medically necessary. Its approval offers the medical community an important tool for managing patients taking dabigatran in emergency or life-threatening situations when bleeding can’t be controlled.
The FDA approved dabigatran in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism. Idarucizumab is the first reversal agent approved specifically for dabigatran and works by binding to the drug compound to neutralize its effect. Idarucizumab solution is for intravenous injection.
Reversing the effect of Idarucizumab exposes patients to the risk of blood clots and stroke from their underlying disease (such as atrial fibrillation). Idarucizumab labeling recommends patients resume their anticoagulant therapy as soon as medically appropriate, as determined by their health care provider.
Idarucizumab is approved under the FDA’s accelerated approval program, which allows the agency to approve drugs for serious conditions that fill an unmet medical need based on an effect on a surrogate or an intermediate clinical endpoint that is reasonably likely to predict a clinical benefit to patients.
The program is designed to provide patients with earlier access to promising new drugs, but the company will be required to submit additional clinical information after approval to confirm the drug’s clinical benefit.