AbbVie's JAK Inhibitor Rinvoq Receives Approval for RA in EU

AbbVie Inc. ABBV announced that the European Commission has granted approval to its JAK inhibitor, Rinvoq (upadacitinib) for the treatment of moderate-to-severe rheumatoid arthritis (“RA”) in patients who experience inadequate response or are intolerant to disease-modifying anti-rheumatic drugs (DMARDs). The drug is approved as a monotherapy or in combination with methotrexate in this patient population.

Please note that the JAK inhibitor had received approval for a similar indication in the United States in August and the early uptake trends of the drug have been encouraging.Rinvoq has generated sales of $14 million in the third quarter since its approval.

Shares of AbbVie have gained 14% in the past six months compared with the industry’s increase of 6%.

The approval for Rinvoq in Europe was based on encouraging data from the phase III SELECT program, which evaluated more than 4000 patients across five phase III studies on RA. In all studies, the drug met every primary and secondary endpoint. Data from the studies under the SELECT program demonstrated that Rinvoq alone or in combination with conventional synthetic DMARDs improved rates of low disease activity and clinical remission in RA patients compared to placebo, MTX or AbbVie’s blockbuster inflammatory drug, Humira (adalimumab).

Humira is the primary revenue generator for AbbVie with global sales of more than $14 billion in the first nine months of 2019. However, the drug’s sales declined significantly in Europe due to the launch of several biosimilars last year from companies including Amgen AMGN, Biogen BIIB and Novartis NVS. Moreover, the drug is set to lose patent protection in the United States, beginning 2023. A similar decline in U.S. sales for the drug will significantly dent AbbVie’s revenues going forward.

We expect Rinvoq and AbbVie’s another new inflammation drug, Skyrizi, to partially offset lost sales for Humira over the long term. However, Humira is approved for 10 different inflammatory indications. AbbVie’s efforts to expand labels of Skyrizi and Rinvoq will further reduce the impact of patent loss for Humira on its revenues, if successful.

In a separate event, the company has reportedly entered into an agreement with the pan-Canadian Pharmaceutical Alliance for the commercialization of Venclexta in combination with J&J’s Rituxan (rituximab) as a treatment for chronic lymphocytic leukemia in second or later-line setting.

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AbbVie currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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