Pamela Spicer, principal analyst at Informa Pharma Intelligence looks at Biogen's recently approved Alzheimer's drug and questions its rollout in countries outside of the US.
Earlier this month, the FDA approved Biogen’s Alzheimer’s drug, Aduhelm, in a decision which many in the industry are calling somewhat controversial. Aduhelm has been labelled by Biogen as the first drug of its kind to target the underlying cause of Alzheimer’s disease. The drug – which was approved through the FDA’s accelerated approval pathway – looks to reduce the build-up of amyloid- beta plaque in the brain in the hope of reducing cognitive decline.
The nature of the FDA’s approval of Aduhelm and the data Biogen has gathered through clinical trials has brought with it many questions from the industry. One of the major concerns many people have is with the cost of Aduhelm – some $56,000 per year depending on the patient’s insurance. This is for a treatment that is still yet to be proven effective and is based on data that indicates a clinical benefit but does not prove it.