SAN DIEGO — Biogen on Thursday presented detailed data making a case for its resurrected Alzheimer’s drug, arguing that its mixed study results can be explained away by differences in whether patients got the highest dose of the medicine.
But the new data deepen sharp questions about the prospects of the drug and are unlikely to convince skeptics who doubt whether the Food and Drug Administration will be willing to approve it. Biogen’s stock was up 1.75% midday on Thursday after its presentation here at the Alzheimer’s research conference known as CTAD.
The drug, known as aducanumab, was tested in two identically designed late-stage studies. Biogen had halted both of those trials in March because the drug appeared to have failed. But in October, the company announced that a new analysis reflecting previously unavailable data showed that the drug actually reduced decline in patients with early-stage Alzheimer’s in one of the studies, called Emerge. The other study, called Engage, failed.
I was on the Ninewells,Dundee drug trial,aducanumab or placebo. People like me with cognitive impairment have lost a prospective lifeline & hopes have been dashed by the cessation of the trial. It’s difficult for a lay person to interpret these results. I was then invited to restart this trial only to read the future is unclear. Myself & others are struggling to stay positive meantime…..