Eisai files, and the sellside endorses the Alzheimer’s opportunity
Eisai and Biogen’s lecanemab (BAN2401) looks to become the next test of the FDA in Alzheimer’s disease. The Japanese firm, which is leading development of the amyloid beta MAb, confirmed yesterday that it had started a rolling submission. Accelerated approval will be sought on the back of Study 201, a phase 2b trial that failed but which the partners believe yielded signals of efficacy. The FDA will decide whether to accept lecanemab’s filing when the submission is complete, which could happen by year end. Importantly, however, a final decision is unlikely before lecanemab's phase 3 Clarity AD study yields data towards the end of 2022. Meanwhile, a very slow Aduhelm launch has not dimmed the sellside’s optimism for the Alzheimer’s opportunity. Consensus forecasts show all four leading MAbs hitting blockbuster status by 2026, according to Evaluate Pharma, an outlook that feels ambitious. The outcome of Medicare’s National Coverage Determination, due early next year, remains hugely important for this outlook. The agency will decide whether the US government should reimburse Aduhelm or restrict its use, a decision that could apply to other antibodies that reach the market. A weak third quarter from Biogen could also send numbers down; second-quarter Aduhelm sales amounted to only $2m.