Biogen is investigating the death of a patient who was taking the company’s recently approved Alzheimer’s treatment, Aduhelm.
According to the Wall Street Journal, the death of a 75-year-old patient was reported to the FDA by a doctor. Biogen said that the patient was diagnosed with “cerebral edema thought to be ARIA-E.”
During late-stage trials of Aduhelm, ARIA-E, a buildup of fluid in the brain, emerged as one of the most common and concerning side effects triggered by the drug, impacting 35% of patients in the studies. Biogen presented data suggesting that about 76% of the cases were asymptomatic and that 98% were eventually resolved on MRI.
Still, when it was approved in June, FDA labeling for the drug advised that Aduhelm patients receive an MRI to screen for ARIA once prior to the seventh infusion at week 28 and another before the 12th infusion at week 48. Yet, questions surrounding the long-term health impacts of ARIA remain, along with concerns over who will foot the bill for the needed scans.
All of the issues have dealt a blow to sales projections for Aduhelm, which, prior to its approval, was forecasted to quickly skyrocket to blockbuster heights. In its first three months on the market, Biogen pulled in just $300,000 from Aduhelm — much lower than analysts’ estimates of $10.79 million.
