www.fdanews.com/articles/206573-bayer-gets-fda-fast-track-status-for-next-generation-blood-thinner
Bayer Gets FDA Fast-Track Status for Next-Generation Blood Thinner
February 14, 2022
The FDA has granted Bayer’s experimental drug asundexian Fast-Track designation as a secondary preventive treatment for patients with noncardioembolic ischemic stroke.
In phase 2 trials for treating irregular heartbeat and recent heart attack, asundexian is being developed as both a standalone therapy and in combination with anti-platelet therapy.
The investigational drug is an oral factor Xla inhibitor, which targets a protein involved in blood clot formation without increasing the risk of bleeding.
The Fast-Track designation is meant to speed the development and review of drugs treating serious conditions that fill an unmet need.