Lilly’s drug Taltz for nr-axSpA meets endpoints in Phase 3 testing, approval application expected this year

Eli lilly is encouraged by the results of the COAST-X trial, which support its belief that Taltz could become the first IL-17A antagonist to be approved in the U.S. for people with non-radiographic axSpA, said Christi Shaw, president, Lilly Bio-Medicines.

In a press release on Monday, in which Lilly said Taltz (ixekizumab) met the primary and all major secondary endpoints in this Phase 3 study testing Taltz for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients who are biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve, Lilly’s bio-medicines president said that the COAST-X data add to the growing body of evidence from its COAST program, which demonstrates that Taltz may work across the axSpA disease spectrum.

According to the press release, Lilly plans to submit detailed data from COAST-X for disclosure at scientific meetings and in peer-reviewed journals later this year. Based on these positive data, Lilly said it plans to submit to regulatory authorities in 2019 for approval for nr-axSpA.

Taltz also met the major secondary endpoints at week 16 and week 52, including significant improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS), significant improvement in Bath Ankylosing Spondylitis Disease Activity (BASDAI), proportion of patients achieving low disease activity (ASDAS <2.1), significant improvement in sacroiliac joint inflammation (SIJ) as assessed by MRI (week 16) and significant improvement in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score, the company said.

“Non-radiographic axSpA is a challenging diagnosis that is not only missed in clinics, but also has limited treatment options for physicians to offer patients,” said professor of medicine Atul Deodhar, from Oregon Health & Science University and clinical investigator for the COAST program.

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