NORTH CHICAGO, Ill. - AbbVie (NYSE: NYSE:ABBV) has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for its drug mirvetuximab soravtansine (ELAHERE) for specific ovarian cancer patients. The recommendation is for the treatment of adults with folate receptor alpha (FRα)-positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have undergone one to three prior treatment regimens.
This endorsement by CHMP is based on the results of the Phase 3 MIRASOL clinical trial, which compared mirvetuximab soravtansine to single-agent chemotherapy in patients expressing high levels of FRα. The trial enrolled 453 patients and assessed progression-free survival as its primary endpoint. The European Commission will make a decision on the marketing authorization of mirvetuximab soravtansine later in the year.
The drug, which is an antibody-drug conjugate targeting cancer cells that express the folate receptor alpha, has already been approved by the FDA in the United States in March 2024. Submissions for marketing authorization are currently under review in other countries.
Ovarian cancer is a leading cause of death among gynecological cancers, with an estimated 320,000 women diagnosed worldwide in 2022. The disease is often diagnosed at a late stage, and while surgery and platinum-based chemotherapy are standard treatments, many patients develop resistance to platinum-based therapies, necessitating alternative treatments.
AbbVie's mirvetuximab soravtansine represents a new option for patients with platinum-resistant ovarian cancer, addressing an unmet medical need in this population. The company is committed to advancing its oncology portfolio, which includes a range of investigational therapies for blood and solid tumors.
The safety profile of ELAHERE includes ocular toxicity, pneumonitis, and peripheral neuropathy among the most common adverse reactions. Patients are advised to undergo ophthalmic exams before and during treatment due to the risk of ocular toxicities. The drug is also associated with embryo-fetal toxicity and is not recommended for use in pregnant women.
This development is part of AbbVie’s broader mission to discover and deliver innovative medicines and solutions for serious health issues. The information reported is based on a press release statement from AbbVie.
In other recent news, AbbVie's subsidiary, Allergan (NYSE:AGN) Aesthetics, has received approval for Botox Cosmetic as a treatment for masseter muscle prominence in China. This development follows a Phase 3 clinical trial indicating a significant reduction in facial width. Allergan Aesthetics is also planning to extend this treatment to other global markets. Furthermore, AbbVie has declared a quarterly cash dividend of $1.55 per share, underscoring its commitment to shareholder returns.
In governance matters, AbbVie has updated its bylaws, including the removal of a contested provision, as part of its efforts to streamline corporate governance. On the analyst front, Deutsche Bank maintained its price target for AbbVie at $175.00, while Piper Sandler and Goldman Sachs raised their price targets to $209 and $200 respectively.
The company has also seen recent product advancements, with the European Commission granting conditional approval for TEPKINLY, a drug for treating adult patients with relapsed or refractory follicular lymphoma. Additionally, Allergan Aesthetics launched a new skincare product, SkinMedica® HA5® Hydra Collagen Replenish + Restore Hydrator. These are the recent developments surrounding AbbVie.
InvestingPro Insights
As AbbVie (NYSE: ABBV) secures a positive opinion from the EMA for its ovarian cancer drug, ELAHERE, the company's financial health and market performance continue to be of interest to investors. With a robust market capitalization of $342.0 billion, AbbVie stands as a significant player in the biopharmaceutical sector. The company has demonstrated a commitment to shareholder value, as evidenced by its history of raising dividends for 12 consecutive years, a trend that aligns with its current dividend yield of 3.21%.
The InvestingPro data highlights a Price/Earnings (P/E) ratio of 64.61, which may indicate a high earnings multiple compared to industry peers. However, when adjusted for the last twelve months as of Q2 2024, the P/E ratio presents a more moderate figure of 26.35. This suggests that investors are pricing in expected earnings growth, supported by the fact that 14 analysts have revised their earnings projections upwards for the upcoming period. This optimism is further backed by a projected net income growth for the year.
Despite trading near its 52-week high, with the price at 96.83% of this peak, AbbVie's stock is known for low price volatility, which could appeal to investors seeking stability. For those interested in a deeper analysis, the InvestingPro platform offers additional insights, with a total of 13 InvestingPro Tips available for AbbVie, including perspectives on the company's profitability and market valuation.
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