Protocols

Biogen, Eisai releases four-year data on aducanumab; EMA stamps Eidos’ aTTR therapy with orphan designation

→ After an attempt to resurrect faith in their Alzheimer’s drug BAN2401, using a small subset of patients from a closely watched Phase II trial on Thursday, Biogen $BIIB and Eisai followed up on Friday with long term data from a Phase I extension study of its other experimental Alzheimer’s drug, aducanumab. The Phase Ib trial now has four years of results, and an analysis of data suggests aducanumab played a role in a continued slowing of clinical decline in patients over 36 months and 48 months, Biogen said.

→ When Eidos $EIDX initiates its trials for TTR amyloidosis next year, it will do so with the blessings of European regulators. The San Francisco-based BridgeBio startup says the EMA has granted a product-specific pediatric investigational plan waiver for AG10 while its orphan product unit has also given thumbs up for the designation. Though Eidos faces a fierce group of rivals including Alnylam $ALNY, Ionis $IONS and even Pfizer $PFE, execs are confident that their drug’s ability to stabilize tetrameric TTR will help it stand out from the competition.

This story has been updated with information from Biogen.


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 33,900+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Scientist, Quality Control
Molecular Templates Austin, TX
Receptionist/Administrative Assistant
Molecular Templates Austin, TX
Principal
Flagship Pioneering Cambridge, MA

Visit Endpoints Careers ->