NORTH CHICAGO, Ill. - AbbVie (NYSE: NYSE:ABBV) today announced the FDA approval of VYALEV™, the first subcutaneous 24-hour continuous infusion therapy for adults with advanced Parkinson's disease. This new treatment is designed to manage motor fluctuations, a common challenge in Parkinson's disease, and allows for personalized dosing throughout the day.
The approval is based on a pivotal Phase 3 study which demonstrated that patients receiving VYALEV experienced better control of motor symptoms, such as increased "on" time without troublesome dyskinesia and decreased "off" time, when compared with those taking oral carbidopa/levodopa. The "on" time refers to periods when patients have optimal motor symptom control, while "off" time is when symptoms return.
Most adverse reactions reported were mild or moderate, with the most frequent being infusion site events, hallucinations, and dyskinesia. The therapy's efficacy and safety were also supported by a 52-week open-label study.
Robert A. Hauser, M.D., a neurology professor and director at the University of South Florida's Parkinson's and Movement Disorder Center, emphasized the significance of this non-surgical option for continuous levodopa delivery.
Parkinson's disease is a progressive neurological disorder affecting over 10 million people globally, characterized by tremor, muscle rigidity, and movement difficulties. As the disease progresses, managing motor fluctuations becomes increasingly challenging.
AbbVie has made VYALEV available in 35 countries and reports over 4,200 patients have begun treatment. Medicare coverage for VYALEV is expected in the second half of 2025. Patients are advised to discuss with their healthcare providers for more information on this treatment.
This news is based on a press release statement.
In other recent news, AbbVie has seen a series of financial and developmental updates. Truist Securities increased AbbVie's stock price target to $215, maintaining a Buy rating. This change is due to an update in the company's financial model, including the anticipation of peak sales of approximately $1 billion for the drug tavapadon. The new revenue forecasts for AbbVie remain unchanged, with estimates set at $55.6 billion for 2024, $59.5 billion for 2025, and $63.7 billion for 2026.
AbbVie also revised its 2024 aesthetics revenue forecast to $5.5 billion, a decrease from the previously projected $5.7 billion, as reported by Morgan Stanley. Furthermore, the company lowered its 2024 profit outlook due to increased research and development costs. Despite these adjustments, Morgan Stanley maintained its Overweight rating on AbbVie shares, with a stable price target of $218.00.
On the development front, AbbVie submitted a Biologics License Application to the U.S. Food and Drug Administration for the approval of Teliso-V, a potential new treatment for a subset of lung cancer patients. BMO Capital Markets highlighted promising clinical trial results for the company's Parkinson's treatment, tavapadon. These are among the recent developments for AbbVie.
InvestingPro Insights
AbbVie's recent FDA approval of VYALEV™ for advanced Parkinson's disease aligns with the company's strong position in the biotechnology industry. According to InvestingPro data, AbbVie boasts a substantial market capitalization of $336.42 billion, reflecting its significant presence in the pharmaceutical sector.
An InvestingPro Tip highlights that AbbVie has raised its dividend for 12 consecutive years, demonstrating a commitment to shareholder value that may appeal to investors interested in the company's new Parkinson's treatment. This consistent dividend growth, coupled with a current dividend yield of 3.26%, could provide an attractive proposition for income-focused investors.
Despite a slight revenue decline of 1.83% over the last twelve months, AbbVie maintains a robust gross profit margin of 69.66%. This strong profitability metric suggests the company has the financial resources to support the rollout and marketing of VYALEV™ across its expanding global market presence.
It's worth noting that AbbVie is trading near its 52-week high, with a price at 95.25% of its peak. This could indicate market confidence in the company's pipeline and recent approvals like VYALEV™. However, investors should be aware that the stock is trading at a high P/E ratio of 63.57, which may reflect high growth expectations.
For those interested in a deeper analysis, InvestingPro offers 12 additional tips for AbbVie, providing a more comprehensive view of the company's financial health and market position.
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