Astellas readies roxadustat for launch

Amid the delays and mishandling that marked Fibrogen’s attempts to get roxadustat to market in the US, it is easy to forget that a different story lies behind the drug’s progress in Europe. Astellas, which owns rights to the novel anaemia pill in that region and Japan, won broad backing from the EMA last month with no hold-ups.

This is not to say that the EU regulators waved roxadustat through. The EMA requested several additional data analyses and subgroup explorations and asked “many tough questions”, according to Salim Mujais, senior vice-president and head of medical specialties at Astellas. “In my over 20 years in industry this was one of the most rigorous and meticulous processes with regulators,” he told Evaluate Vantage.