Biogen's $200M expansion is another boost to NC's growing biopharma sector The FDA has faced an intense public backlash since approving the drug, which costs $56,000-a-year and requires monthly IVs. On Thursday, the agency took the unusual step of vastly scaling back prescribing information on the drug. The agency and Biogen announced the new label would recommend it only be given to patients with mild or early-stage Alzheimer's. That came after many doctors criticized the original label as too broad — stating only that it could be used in anyone with Alzheimer's. Aduhelm hasn't been shown to reverse or significantly slow the disease. But the FDA said that its ability to reduce clumps of plaque in the brain is likely to slow dementia. Biogen is required to conduct a follow-up study to definitively answer whether it really works. Other Alzheimer's drugs only temporarily ease symptoms. Woodcock has been serving as the agency's acting commissioner since January.