...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: Biogen looks to FDA for approval of early Alzheimers drug.

Published: Oct 22, 2019 6:39 a.m. ET

Biogen BIIB, +33.32% said it will pursue regulatory approval for aducanumab, an investigational treatment for early Alzheimer's disease after consulting with the U.S. Food and Drug Administration. A Phase 3 trial met its primary endpoint showing a significant reduction in clinical decline, and Biogen believes that results from a subset of patients in the study who received sufficient exposure to high dose aducanumab support the finding. The decision to file is based on a new analysis, conducted by Biogen in consultation with the FDA, of a larger dataset from the Phase 3 clinical studies that were discontinued in March 2019 following a futility analysis.

 

2
Oct 22, 2019 01:52PM
2
Oct 22, 2019 02:04PM
2
Oct 22, 2019 02:33PM
1
Oct 22, 2019 02:46PM
1
Oct 22, 2019 03:36PM
1
Oct 22, 2019 03:57PM
2
Oct 22, 2019 04:07PM
3
Oct 22, 2019 05:15PM
3
Oct 22, 2019 05:29PM
4
Oct 22, 2019 05:54PM
3
Oct 22, 2019 06:32PM
4
Oct 22, 2019 06:37PM
4
Oct 22, 2019 07:23PM
5
Oct 22, 2019 09:34PM
9
Oct 22, 2019 11:59PM
3
Oct 23, 2019 01:53AM
2
Oct 23, 2019 07:17AM
4
Oct 23, 2019 08:02AM
1
Oct 23, 2019 08:19AM
2
Oct 23, 2019 08:50AM
1
Oct 23, 2019 09:23AM
2
Oct 23, 2019 10:44AM
1
Oct 23, 2019 12:40PM
1
Oct 23, 2019 12:41PM
3
Oct 23, 2019 12:49PM
2
Oct 23, 2019 12:59PM
4
Oct 23, 2019 01:03PM
Share
New Message
Please login to post a reply