How Will AbbVie Upadacitinib For Giant Cell Arteritis Affect AbbVie Stocks?

AbbVie (ABBV) has submitted applications to the FDA and EMA for the use of upadacitinib (RINVOQ®) in treating giant cell arteritis (GCA). The submissions are backed by the results of the SELECT-GCA Phase 3 study, which demonstrated that a 15 mg dose of upadacitinib, coupled with a 26-week steroid taper, achieved the primary endpoint of sustained remission from weeks 12 to 52. This move could significantly impact AbbVie stocks by expanding the drug’s market and addressing a critical medical need.

Clinical Evidence Supporting Upadacitinib

The safety profile of upadacitinib in GCA patients was generally consistent with that observed in approved indications. GCA is an autoimmune disease affecting medium and large arteries, leading to symptoms such as headaches, jaw pain, and visual changes, including sudden and irreversible vision loss. The successful results from the SELECT-GCA study underscore the potential of upadacitinib to provide a new treatment option for GCA, potentially boosting investor confidence in AbbVie stocks.

The Need for New GCA Treatments

“Currently, there are limited approved treatment options for patients with GCA. Most patients are prescribed glucocorticoids, and many are unable to discontinue their use without experiencing a relapse of GCA symptoms,” stated Rupal Thakkar, M.D., Executive Vice President of Research and Development and Chief Scientific Officer at AbbVie. “We recognize the importance of maintaining remission and limiting glucocorticoid use in GCA.” This statement highlights the unmet medical need that upadacitinib aims to address, which could positively influence AbbVie stocks as the company pioneers new therapeutic approaches.

Regulatory Filings and Study Outcomes

The regulatory filings with the FDA and EMA are supported by previously announced results from the Phase 3 SELECT-GCA study, which evaluated the safety and efficacy of upadacitinib in patients with GCA. This study’s findings not only reinforce upadacitinib’s potential but also align with AbbVie’s strategic goals to innovate and expand its product pipeline. Positive regulatory outcomes could drive significant growth in AbbVie stocks, reflecting the company’s ongoing commitment to addressing complex diseases.

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