The European Commission and Japan's Ministry of Health, Labor and Welfare approved filgotinib, marketed under the name Jyseleca, for rheumatoid arthritis. The drug is partnered in Japan with Eisai. The FDA rejected the drug last month.
While there had been some risks to filgotinib's approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.
By reducing administrative burden and redesigning workflows around human needs, it creates space for what matters most: connection between clinicians and patients.
An analyst wrote that while filgotinib's profile appears clean overall, even minor safety imbalances could derail its approval, while a slight imbalance in the number of deaths between the Phase III study arms could also attract scrutiny.
The collaboration includes six drugs in development and more than 20 in preclinical development. It also amends an existing four-year-old partnership the two companies had regarding the autoimmune disease drug filgotinib.
The timing of the filing appears to allay concerns that the FDA would require completion of a study evaluating the testicular safety of the drug, filgotinib, and thus push its launch date from 2020 to 2021-22, an analyst wrote.