AbbVie Submits Application to FDA for RINVOQ
On Tuesday, after the closing bell, AbbVie announced that they submitted an application to the FDA for RINVOQ, a JAK inhibitor, for treating adult patients with active ankylosing spondylitis. “The applications to the FDA and EMA are supported by data from SELECT-AXIS 1, a Phase 2/3 study in which RINVOQ demonstrated significant improvements in signs and symptoms in patients with active ankylosing spondylitis.”
RINVOQ is used to reduce joint pain, swelling, and stiffness in adults with moderate-to-severe rheumatoid arthritis who had an inadequate response or intolerance to methotrexate.
Michael Severino, M.D., vice chairman and president of AbbVie said, "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.”
Being that RINVOQ is a big factor in the pipeline and a main driving force for growth of global sales, the approval from the FDA can advance the overall growth of AbbVie.
Last week, Morgan Stanley raised the price target from $95 to $108 based upon uptake of new launches and prospects for long-term multiple expansion. They expect AbbVie to grow strongly over the next few years, driven by seven key assets, one of them being RINVOQ.
RINVOQ is a recent launch within Abbvie’s immunology portfolio and has a sales forecast of $600 million for the quarter. "Rinvoq has really stood up and rapidly started to capture share. It's at 15% and growing at a very aggressive clip. I would predict that it will quickly become the in-play market leader above HUMIRA here in the not-too-distant future," CEO Richard Gonzalez said on the second quarter earnings call.
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