Alzheimer’s drug shows positive outcomes in genetic variant-based trial
When US-based biotechnology company Biogen introduced an experimental drug to treat Alzheimer’s disease (AD), it was expected to become the first drug to successfully slow the disease’s progression, and would mark a great achievement in the medical world. Unfortunately, Biogen suspended those drug trials early this year after a “futility analysis” indicated patients on the drug course were unlikely to show substantial improvement.
Despite the allegations, the company continued to administer the drug to patients with a certain genetic variation at higher dosages. Biogen spent the next several months parsing the new patient data and discovered that a cohort of patients in one these trials exhibited less cognitive decline.
The US Food and Drug Administration (FDA) suggested Biogen run more analysis as some patients are likely to benefit from treatments based on biomarkers or genetic variants over randomised, placebo-controlled trials. While alternative trial designs have generated resistance from some in the medical community, Biogen’s trial results have demonstrated positive effects in its participants and may encourage more research: “The evidence came over time. We collected a tremendous and complex set of data, including biomarkers and imaging,” said CEO Michel Vounatsos.
Biogen has recently met and received written comments from the FDA, and will seek approval for their breakthrough Alzheimer’s drug, which could spell hope for about six million Americans and more around the globe who suffer from AD.
Category: Features, Pharmaceuticals
