Michel Vounatsos, Biogen CEO (via YouTube)

FDA OKs ad­u­canum­ab for Alzheimer's, turn­ing con­tro­ver­sial Bio­gen drug in­to a megablock­buster

The FDA has ap­proved the Bio­gen drug ad­u­canum­ab for Alzheimer’s, a stun­ning de­ci­sion that caps near­ly two years of con­tro­ver­sy and hands the large biotech a mega-block­buster that could earn more than $10 bil­lion per year.

The de­ci­sion makes ad­u­canum­ab — now mar­ket­ed as Aduhelm — the first drug specif­i­cal­ly ap­proved to slow the pro­gres­sion of the dev­as­tat­ing mem­o­ry-wast­ing dis­ease, a mile­stone that pa­tient ad­vo­ca­cy groups and some lead­ing neu­rol­o­gists hailed for months lead­ing up to the FDA’s dead­line. Pri­or to ad­u­canum­ab, near­ly every ef­fort to treat Alzheimer’s had failed, even as the num­ber of Amer­i­cans liv­ing with the dis­or­der swelled past 6 mil­lion. The last ap­proved drug came in 2003 and on­ly tem­porar­i­ly boosts mem­o­ry.

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