The earliest possible date that solanezumab is likely to reach the US Alzheimer’s market is now the end of 2017, four years later than Eli Lilly had initially hoped when it started its EXPEDITION clinical trial program. Assuming approval in mild Alzheimer’s disease, with additional off-label use in MCI patients, Datamonitor forecasts solanezumab to achieve sales of $4.0 billion across the seven major markets (the US, Japan, France, Germany, Italy, Spain and the UK) in 2021.
That is because Lilly is to test its experimental Alzheimer’s antibody in another Phase III trial, targeting mild patients only. Discussions with the FDA dissuaded Lilly from seeking immediate approval with a mild-to-moderate indication