Since Biogen brought aducanumab back from the dead, it’s kept tight-lipped on its plans for the once-failed Alzheimer’s hopeful, letting analysts speculate in January that a filing would come “within weeks.” Now, four months—and no filing—later, the company is spilling the beans. It will complete the application in the third quarter.
The company has started submitting modules of a Biologics License Application (BLA) to the FDA and is preparing for a pre-BLA meeting with the agency slated for this summer, according to Biogen’s first-quarter earnings statement (PDF). Analysts, who had previously anticipated a potential 2020 approval, pushed their expectations out as far as 2022.
The announcement comes a week after life sciences data firm GlobalData said “the filing and review of Biogen’s recombinant human monoclonal antibody (mAb) aducanumab is expected to take more than was estimated.” In a report, GlobalData pointed out that many trials for Alzheimer’s meds are at risk of delays because most patients required to test these drugs are being told to self-isolate during the COVID-19 pandemic.
Biogen executives, however, are focusing on the data.
With a “complex and unprecedented” data set, including multiple biomarkers and multiple endpoints, the company is “prioritizing quality of submission versus the timing,” said Biogen CEO Michel Vounatsos on Biogen’s first-quarter earnings call.
“Nothing has come up in the data that changes our interpretation of the data,” said Biogen’s R&D chief Al Sandrock, M.D., Ph.D., on the call, adding that the company had always planned to have a pre-BLA meeting with the FDA. He acknowledged challenges of working during a pandemic with “some members of the team” coming down with COVID-19.
SPECIAL REPORT: Top biotech money raisers of 2019
Jefferies analyst Michael Yee expects the PDUFA date for aducanumab to fall in 2021, according to an investor note, while Wolfe Research’s Tim Anderson wrote that the delay in approval could stretch out into “2022?”
“Today’s update suggests slower discussions w/FDA vs. what BIIB initially had in mind, potentially supportive of our view,” Anderson wrote. “In terms of other pipeline comments, BIIB says that despite COVID-19, it continues to expect the vast majority of its 10 near-term readouts to be on time.”