NORTH CHICAGO, Ill. - AbbVie (NYSE: NYSE:ABBV) has announced results from its Phase 3 SELECT-GCA study, indicating that upadacitinib (RINVOQ®; 15 mg), combined with a 26-week steroid taper regimen, achieved sustained remission in 46 percent of patients with giant cell arteritis (GCA) from week 12 through week 52.
This compares to 29 percent of patients on a placebo with a 52-week steroid taper regimen. The study met both its primary endpoint and key secondary endpoints, with a higher percentage of patients on upadacitinib achieving sustained complete remission.
GCA is an autoimmune disease causing inflammation of large arteries, primarily affecting individuals over 50, with women at higher risk. Symptoms can include headaches, jaw pain, and vision changes, with the possibility of sudden and permanent vision loss. The SELECT-GCA study aimed to provide a new treatment option for this patient population, which currently has limited therapies available.
The trial's lead investigator, Daniel Blockmans, M.D., Ph.D., expressed optimism about the potential of upadacitinib as the first oral treatment option for GCA. The safety profile of the drug during the 52-week study was consistent with its approved indications, and no new safety signals were identified. The rate of serious adverse events was similar between the upadacitinib and placebo groups, with serious infections slightly lower in the upadacitinib group.
Despite not being approved for GCA treatment yet, these findings suggest upadacitinib's promise to address the significant unmet medical need in this area. AbbVie's history in developing treatments for immune-mediated diseases is reflected in this clinical program.
Full study results are expected to be presented at a future medical meeting, and the safety and efficacy of upadacitinib in GCA have not been evaluated by regulatory authorities.
These findings are based on a press release statement from AbbVie.
InvestingPro Insights
In light of AbbVie's recent announcement on the promising results of upadacitinib for treating giant cell arteritis (GCA), investors may find the following insights from InvestingPro particularly relevant. AbbVie (NYSE: ABBV) has demonstrated a commitment to increasing shareholder value, as evidenced by its track record of raising its dividend for 11 consecutive years, a testament to the company's financial health and management's confidence in its future prospects (InvestingPro Tip 0).
Moreover, the company's valuation suggests a strong free cash flow yield, indicating that AbbVie could have the financial flexibility to continue investing in its drug pipeline and potentially bring new treatments like upadacitinib to market (InvestingPro Tip 3).
From a financial standpoint, AbbVie's market capitalization stands at a robust 290.83 billion USD, underscoring its significant presence in the biotechnology industry. The company's Price/Earnings (P/E) ratio, adjusted for the last twelve months as of Q4 2023, is 21.99, which might be considered high in relation to the industry average, suggesting that investors are expecting higher earnings growth in the future (InvestingPro Data). This aligns with the expectation that AbbVie's net income is projected to grow this year (InvestingPro Tip 1).
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