The race for coronavirus treatments and vaccines rages on. But while COVID 19 has understandably been at the forefront of the medical community’s—and public’s—mind, this pandemic hasn’t just erased the need for therapies which can treat diseases ranging from neuromuscular disorders to pathologies like Alzheimer’s and dementia which have no effective approved treatments.
The world’s focus has been on the virus. But drug makers continue to work on various other therapies in a challenging environment.
For instance: Prior to the COVID crisis, one of the most ballyhooed treatments in the biopharma space was aducanumab, the experimental Alzheimer’s treatment from drug giant Biogen which could potentially become the first approved therapy for Alzheimer’s—a treatment that doesn’t just treat symptoms, but the underlying disease (although it comes with its fair share of controversies).
Those controversies share similarities with concerns around a rush to get a COVID vaccine across the regulatory finish line. Since Biogen’s drug would be the first of its kind (as would any coronavirus treatment), the FDA decided in August 2020 to put it on a fast track designation, meaning that the regulatory review process could be slashed by four months—and that was after the company initially decided the treatment probably wouldn’t work out before reversing course in a stunner in 2019.
“It was a gradual understanding,” Biogen’s chief medical officer Alfred Sandrock told Fortune late last year after deciding to submit the drug for regulatory approval.
The FDA fast track puts aducanumab on path to potential approval by March 2021. And that’s at the latest. It could well receive a decision ahead of that time.
Aducanumab works by targeting so-called amyloid plaques, which are proteins that build up in the brain and are common among dementia patients. This particular theory of treating Alzheimer’s or dementia hasn’t been proven to date—but Biogen is hoping to break the mold. The drug’s purpose isn’t so much to reverse the disease as to slow its progression, although that would in and of itself represent progress.
On top of that, the FDA’s advisory committee calendar—the schedule for what are essentially hearings on drugs’ safety and efficacy following clinical trials and debated by experts—includes other treatments such as an Alkermes drug for schizophrenia and bipolar disorder, as well as meetings in October to assess medical devices that can treat heart disorders.
