AbbVie submits Rinvoq for ankylosing spondylitis

by | 26th Aug 2020 | News

In a pivotal Phase II/III study, twice as many patients receiving the drug achieved the primary endpoint of ASAS 40 response at week 14 versus placebo

AbbVie has filed for approval of Rinvoq (upadacitinib) in the US to treat adult patients with active ankylosing spondylitis.

Ankylosing spondylitis is a chronic, progressive, inflammatory musculoskeletal disease impacting more than five million people worldwide, with a range of symptoms posing significant physical, psychological and economic burden on affected individuals.

The application is supported by data from SELECT-AXIS 1, in which the JAK inhibitor demonstrated significant improvements in signs and symptoms in patients with active ankylosing spondylitis, with twice as many patients (52%) achieving an (ASAS) 40 response versus placebo (26%).

“Ankylosing spondylitis is a debilitating disease that can cause severe pain, restricted mobility and lasting structural damage. With limited treatment options, innovation is crucial to help more patients living with active ankylosing spondylitis reach their treatment goals,” said Michael Severino, vice chairman and president, AbbVie.

“Rinvoq has the potential to improve care by helping to provide disease control, addressing pain and improving function.”

A regulatory application was also submitted to the EMA for the treatment of adult patients with active ankylosing spondylitis earlier this year, the firm noted.

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