mp.weixin.qq.com·· 9 hours agoPickScore89
NMPA Approves Bayer's Asundexian, World's First Factor XIa Inhibitor, First Globally in China
In brief
Bayer's asundexian has been approved by China's NMPA to reduce stroke risk in adults with ischemic stroke or high-risk transient ischemic attack (TIA), marking the drug's first approval worldwide. The indication excludes patients with cardioembolic stroke. The application received priority review and was approved roughly six months after acceptance.
Why it matters
The article gives OCEANIC-STROKE global 26% and Chinese subgroup 32% ischemic stroke risk reductions, HR 0.68 and major bleeding results, enabling comparison of local and global data.
Source: mp.weixin.qq.com · mp.weixin.qq.com