Biogen, in reversal, will seek FDA approval for Alzheimer’s drug : aducanumab

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Biogen CEO Michel Vounatsos said Tuesday the drug manufacturer will seek regulatory approval early next year for an Alzheimer’s disease drug that had been considered a lost cause after the company pulled the plug on late-stage studies because of disappointing results.

 

Biogen CEO Michel Vounatsos said Tuesday the drug manufacturer will seek regulatory approval early next year for an Alzheimer’s disease drug that had been considered a lost cause after the company pulled the plug on late-stage studies because of disappointing results.

Biogen officials took a closer look at study data that it did not have when it halted efforts in March, prompting the reversal. The new data indicated the drug did work in patients who received the highest dose in one of the studies.

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The company says it plans to seek approval for aducanumab in early 2020 and will continue talks with regulatory authorities in international markets, including Europe and Japan. If approved, the drug would be the first to slow cognitive decline in Alzheimer’s patients.

Given the lack of treatments, patients and investors had been excited by aducanumab’s potential when it started two Phase III trials to see whether it worked and should be approved. P. Murali Doraiswamy, MD, professor of psychiatry and behavioral sciences at Duke University School of Medicine, says the new data Biogen released looks encouraging but more detailed results are needed before drawing any definitive conclusions whether aducanumab works.

Biogen’s plan to use two discontinued studies for a new drug approval is unusual, not least because making public that the studies had failed could introduce bias into the results from trial investigators, Doraiswamy says.

Continue at:  https://www.pharmacist.com/article/biogen-reversal-will-seek-fda-approval-alzheimers-drug

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