Boehringer's Pradaxa fails to meet Phase 3 endpoint in preventing recurrent stroke

Boehringer has announced that Pradaxa (dabigatran etexilate mesylate) has failed to meet its primary endpoint in its Phase 3 study, proving unable to show superiority over acetylsalicylic acid (ASA) in preventing recurrent stroke in patients with embolic stroke of undetermined source (ESUS).

The drug particularly failed to present a statistically significant difference in the risk of recurrent stroke. The manufacturer did, however, note that after one year of treatment, a trend emerged showing Pradaxa to improve this very metric over ASA.

Safety data was “not significantly different” between the two therapies, with Boehringer framing the results as a win for the safety profile of its drug, arguing “the results add to the wealth of evidence supporting the established safety profile of Pradaxa.”

“At Boehringer Ingelheim, we are committed to generating new evidence on our treatments and the potential role they can play for patients in areas where there is a high unmet need,” commented Dr Thomas Seck, Senior Vice President, Medicine and Regulatory Affairs at the company. “We are proud to share these results and advance the scientific understanding of ESUS, as well as provide new information on Pradaxa's safety profile.”

Matt Fellows