February 7, 2018 Biogen, Stroke, SETBACK
- 抗α4インテグリン抗体ナタリズマブ（販売名：タイサブリ）は急性血栓性脳卒中に対して効果を示さなかった。バイオジェンがフェーズ2b試験の速報結果を発表。
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen (Nasdaq: BIIB) announced today that in the Phase 2b dose-ranging ACTION 2 study in individuals with acute ischemic stroke (AIS), natalizumab did not demonstrate improvement in clinical outcomes compared to placebo. Both doses of natalizumab were generally well-tolerated and no new or important safety signals were observed. The results of the Phase 2b ACTION 2 study do not impact the benefit-risk profile of natalizumab in approved indications, including multiple sclerosis.
“As pioneers in neuroscience, Biogen remains committed to developing treatments for people with acute neurological conditions including stroke,” said Michael Ehlers, executive vice president, Research & Development at Biogen. “While we are disappointed with the ACTION 2 study results, we have furthered our knowledge of the disease and will continue to pursue innovative approaches in this area, including BIIB093 (intravenous glibenclamide) for prevention and treatment of edema in large hemispheric infarction, one of the most severe types of stroke.”
In the middle of 2018, Biogen plans to initiate a global Phase 3 study of BIIB093 in individuals with large hemispheric infarction, where brain swelling (cerebral edema) often leads to high morbidity and mortality.
