Alexion prepares filings for new rare disease use for Soliris

Alexion is preparing filings in major markets for its rare disease drug Soliris in a new indication after a positive readout in a rare neurological disease. The Boston biotech enjoys blockbuster revenues thanks to Soliris, which is already approved in three other rare diseases. Approved since 2007 in paroxysmal nocturnal hemoglobinuria (PNH), Soliris is reaching the end of its patent life in the US and EU, where protection ends in 2021 and 2020 respectively.
Rival companies including Amgen are trying to market cheaper near-copy biosimilars to steal market share once the legal protection expires. Alexion hopes to squeeze further sales out of Soliris (eculizumab) after results in patients with anti-aquaporin-4 (AQP4) autoantibody-positive neuromyelitis optica spectrum disorder (NMOSD).