The race for coronavirus treatments and vaccines continues. But while COVID 19 has understandably been at the forefront of the minds of the medical community and the public, this pandemic has not only erased the need for therapies that can treat diseases ranging from neuromuscular disorders to pathologies such as Alzheimer’s and dementia, What do they do. . without having effective approval. offers.
The world’s focus has been on the virus. But drug manufacturers continue to work on various other therapies in a challenging environment.
For example: before the COVID crisis, one of the most publicized treatments in the biopharmaceutical space was aducanumab, the experimental Alzheimer’s treatment from pharmaceutical giant Biogen, which could become the first approved therapy for Alzheimer’s, a treatment that It doesn’t just treat the symptoms. but the underlying disease (although it does come with its fair share of controversy).
Since Biogen’s drug would be the first of its kind (as would any coronavirus treatment), the FDA decided in August 2020 to place it in a fast-track designation, which means that the regulatory review process could be shortened by four months, and that was. Initially, the company decided that the treatment would likely not work before changing the course to a stunner in 2019.
The FDA fast track puts aducanumab on track for possible approval by March 2021. And that’s at the latest. You can also receive a decision before that date.
Aducanumab works by targeting so-called amyloid plaques, which are proteins that accumulate in the brain and are common in patients with dementia. This particular theory of treating Alzheimer’s or dementia has not been proven to date, but Biogen hopes to break the mold. The purpose of the drug is not so much to reverse the disease as to slow its progression, although that in itself would represent progress.
In addition to that, the FDA advisory committee program (the program of what are essentially hearings on the safety and efficacy of drugs after clinical trials and discussed by experts), as well as meetings. . . in October to evaluate medical devices that can treat heart disorders.
