FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s con­tro­ver­sial ap­proval of Bio­gen’s Aduhelm drug for Alzheimer’s dis­ease has been met with fierce re­sis­tance from all cor­ners of the bio­phar­ma in­dus­try, but few seem to be as up­set with the de­ci­sion as ALS pa­tients and ad­vo­ca­cy groups.

For all that’s al­ready been writ­ten and dis­cussed about the agency’s an­nounce­ment, from the drug’s ex­or­bi­tant­ly high price of $56,000 per year to crit­i­cism over low­ered stan­dards, ALS pa­tients see some­thing more. ALS pa­tients and as­so­ci­a­tions say they large­ly re­gard­ed Aduhelm’s ap­proval as a bit­ter­sweet dou­ble stan­dard: hap­py that those with Alzheimer’s have a new drug avail­able, but ques­tion­ing how the FDA eval­u­at­ed Bio­gen’s drug com­pared to the ex­per­i­men­tal pro­grams be­ing stud­ied for their own dis­ease.

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