5-Year Data on Secukinumab in AS; Oliceridine Not Recommended for FDA Approval

The new drug application for oliceridine was accepted for FDA review on Jan. 2, 2018, with a Prescription Drug User Fee Act date of completion by Nov. 2, 2018.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

Baraliakos X, Braun J, Deodhar AA, et al. Long-term evaluation of secukinumab in ankylosing spondylitis: 5 year efficacy and safety results from a phase 3 trial [abstract]. Arthritis Rheumatol. 2018; 70(suppl 10).
Trevena Inc. News release: Trevena announces oliceridine FDA advisory committee meeting outcome. 2018 Oct 11.
Trevena Inc. News release: Trevena receives complete response letter for oliceridine from FDA. 2018 Nov 2.

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