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.