Biogen gains fast-track Alzheimer’s drug review in wake of early data

Biogen gains fast-track Alzheimer’s drug review in wake of early data

Biogen gains fast-track Alzheimer’s drug review in wake of early data

After releasing early data just a day ago that grabbed international headlines, now Biogen ($BIIB) has disclosed that its aducanumab to treat Alzheimer’s disease has been granted fast-track designation from the FDA.

It follows in the footsteps of another Alzheimer’s disease candidate from partners Eli Lilly ($LLY) and AstraZeneca ($AZN) that a couple of weeks ago got the same designation for their Phase III BACE inhibitor AZD3293. The Biogen candidate is earlier stage, but aducanumab is moving along quickly. The newly reported data is preclinical and Phase Ib; the candidate is already in a pair of Phase III trials, both in early Alzheimer’s patients.

In the Phase Ib, placebo-controlled trial in 165 prodromal (or predementia) and mild AD patients, aducanumab was found to reduce amyloid-beta in the brain in a dose-dependent fashion. Exploratory data in that trial also found dose- and time-dependent slowing of clinical decline.

“The combination of a much better understanding of disease biology, the focus on genetically validated targets, the use of biomarkers to learn early whether or not our compounds are having the desired biological effects, and the adoption of multiple therapeutic modalities may meaningful increase success rates and identify those projects likely to fail early in the process, before large amounts of time and money are spent,” Biogen CEO George Scangos summed up on a conference call earlier this year of the company’s neurodegenerative research, in general, and aducanumab, in particular.

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