Lilly gains FDA nod as first IL-17A antagonist for nr-axSpA

The US Food and Drug Administration has approved a supplemental Biologics License Application (sBLA) for Taltz (ixekizumab) injection 80mg/mL for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation, submitted by US pharma major Eli Lilly (NYSE: LLY).

Another first-in-class milestone for the treatment, today's approval makes Taltz the first interleukin (IL)-17A antagonist to be approved by the FDA for nr-axSpA, says Lilly, whose shares were barely moved by the positive news.

Until this latest nod for Taltz, Novartis' (NOVN: VX) competing drug Cosentyx (secukinumab) has led the IL-17 class by total prescription numbers. Cosentyx, which generated first-quarter 2020 global sales of $930 million, gained European approval for or nr-axSpA in April this year and is under US and Japanese review for this indication. First-quarter sales of Taltz were $443.5 million.