AbbVie Updates RINVOQ Indications for the Treatment of RA in the U.S.

Biopharmaceutical company AbbVie (ABBV) updated the U.S. Prescribing Information and Medication Guide for RINVOQ (upadacitinib), a selective JAK inhibitor designed to treat adults with moderate to severe rheumatoid arthritis (RA). 

Reason for Update  

On September 1, 2021, a Drug Safety Communication (DSC) was issued by the U.S. Food and Drug Administration (FDA) after a final review of the post-marketing study, ORAL Surveillance. The study evaluated XELJANZ (tofacitinib) in patients with RA. Results of the study showed that XELJANZ (a JAK inhibitor) was more prone to major adverse cardiac events (MACE), malignancy, mortality, and thrombosis than TNF blockers.

Therefore, the DSC and the label update apply to the class of systemically administered FDA-approved JAKs designed for the treatment of RA and other inflammatory diseases.

Following the FDA’s update, RINVOQ will now reflect some additional information in the U.S. label related to its risks. This will include malignancy and thrombosis, as well as mortality and MACE (including cardiovascular death, myocardial infarction, and stroke) risks. Furthermore, the updated indication will stand as; “RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.” (See AbbVie stock charts on TipRanks) 

Official Comments 

President of AbbVie, Michael Severino, said, “RINVOQ is an important treatment option for people living with rheumatoid arthritis, especially those who have not been able to achieve remission or low disease activity. We remain committed to continue generating evidence that support its benefit-risk profile across many inflammatory conditions.” 

Notably, review of supplemental New Drug Applications (NDAs) for upadacitinib (RINVOQ) in atopic dermatitis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis are ongoing with the FDA.   

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Wall Street’s Take 

On November 29, UBS analyst Navin Jacob reiterated a Buy rating on the stock and lifted the price target to $129 (8.54% upside potential) from $126. 

Consensus among analysts is a Strong Buy based on 10 Buys versus 2 Holds. The average AbbVie price target of $132.17 implies 11.21% upside potential from current levels. Shares have gained 12.3% over the past year. 

Bloggers Weigh In 

TipRanks data shows that financial blogger opinions are 100% Bullish on AbbVie, compared to a sector average of 69%.

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