Bio­gen nar­rows its Aduhelm la­bel af­ter FDA left the flood­gates open

While the FDA had con­tro­ver­sial­ly ap­proved Bio­gen’s new Alzheimer’s drug Aduhelm with a wide la­bel for any­one with the de­bil­i­tat­ing dis­ease, Bio­gen an­nounced Thurs­day morn­ing that it’s nar­row­ing the drug’s la­bel as part of an at­tempt to calm at least some of its fiercest crit­ics.

The un­prece­dent­ed move means that the la­bel now says that Aduhelm should be ini­ti­at­ed in pa­tients with mild cog­ni­tive im­pair­ment due to Alzheimer’s dis­ease or mild Alzheimer’s de­men­tia, which is re­flec­tive of the pop­u­la­tion in Bio­gen’s failed but res­ur­rect­ed clin­i­cal tri­als for the drug. The nar­rowed pop­u­la­tion may lim­it how much Medicare ends up spend­ing on the drug, al­though if even a frac­tion of those with Alzheimer’s gain ac­cess to the drug, Bio­gen is like­ly to reap tens of bil­lions of dol­lars per year from it.

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