REUTERS: Biogen Inc revived plans on Tuesday to seek U.S. approval for Alzheimer's treatment aducanumab, surprising investors and saying data from more patients in two discontinued studies showed the drug reduced the decline of patients suffering from the disease.
Filing with U.S. regulators could"potentially bring back to life a drug that had been completely left for dead," RBC Capital Markets analyst Brian Abrahams wrote in a note. The company said that the results of patients in the failed second trial who had received high doses also supported the findings of the first.
"They thought it was reasonable for us to submit an application for approval," said Chief Medical Officer Alfred Sandrock, who earlier this month become the company's R&D head. Baird analyst Brian Skorney said he believed FDA approval for aducanumab was highly unlikely and predicted Biogen would have an uphill task to convince regulators that the results were nothing more than random chance.
Health Health Latest News, Health Health Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Source: ChannelNewsAsia - 🏆 6. / 66 Read more »
Source: ChannelNewsAsia - 🏆 6. / 66 Read more »
Source: ChannelNewsAsia - 🏆 6. / 66 Read more »
Source: ChannelNewsAsia - 🏆 6. / 66 Read more »