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NORTH CHICAGO - AbbVie (NYSE:ABBV), a prominent player in the biotechnology industry with a market capitalization of $337.77 billion, announced Wednesday that its drug upadacitinib (RINVOQ) demonstrated significant efficacy in treating severe alopecia areata, with more than half of patients on the higher dose achieving substantial hair regrowth. According to InvestingPro analysis, AbbVie is currently trading near its Fair Value, reflecting investor confidence in its robust drug development pipeline.
In Study 2 of the Phase 3 UP-AA clinical program, 54.3% of patients receiving the 30 mg dose and 44.6% of those on the 15 mg dose achieved at least 80% scalp hair coverage after 24 weeks of treatment, compared to just 3.4% in the placebo group. This promising development adds to AbbVie’s strong financial performance, with the company generating $57.37 billion in revenue and maintaining an impressive 71.01% gross profit margin.
The trial also met key secondary endpoints, with 47.1% of patients on the higher dose and 36.0% on the lower dose achieving 90% or more scalp hair coverage. Improvements were also noted in eyebrow and eyelash regrowth, with some patients achieving complete scalp hair coverage.
"The safety profile in alopecia areata was generally consistent with that in approved indications," AbbVie stated in its press release. The most common treatment-emergent adverse events included acne, nasopharyngitis, and upper respiratory tract infection.
Serious adverse events occurred in 1.4% and 2.8% of patients in the 15 mg and 30 mg groups respectively, with no reports in the placebo group. One case of venous thromboembolism was reported in a patient with multiple risk factors who received the lower dose.
Alopecia areata is an immune-mediated disease that can cause total hair loss affecting the scalp, eyebrows, and eyelashes. Results from a parallel replicate study (Study 1) are expected later this quarter. InvestingPro subscribers can access detailed financial health analysis and 12+ additional ProTips about AbbVie’s market position and growth potential through comprehensive Pro Research Reports, available for over 1,400 top US stocks.
Upadacitinib is currently approved for several other conditions including rheumatoid arthritis, psoriatic arthritis, and atopic dermatitis, but its use for alopecia areata has not yet received regulatory approval.
The information in this article is based on a press release statement from AbbVie.
In other recent news, AbbVie has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for a new combination therapy to treat chronic lymphocytic leukemia (CLL). The therapy, which includes VENCLEXTA and acalabrutinib, showed promising results in a Phase 3 trial by reducing the risk of disease progression or death by 35% compared to standard treatments. Additionally, AbbVie has entered into an exclusive licensing agreement with IGI Therapeutics for the investigational cancer therapy ISB 2001, currently in Phase 1 trials for multiple myeloma. The agreement involves a $700 million upfront payment to IGI, with potential milestone payments reaching up to $1.225 billion. AbbVie will have exclusive rights to develop and commercialize ISB 2001 in several major markets, including North America and Europe. In analyst news, JPMorgan has maintained its Overweight rating on AbbVie, setting a price target of $200 ahead of the company’s upcoming earnings report. The firm anticipates strong performance from AbbVie’s products, Skyrizi and Rinvoq, contributing to positive earnings expectations.
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