NEW YORK - Pfizer Inc. (NYSE: NYSE:PFE) has announced the global withdrawal of its sickle cell disease (SCD) treatment, OXBRYTA® (voxelotor), due to safety concerns. The pharmaceutical giant is also halting all active clinical trials and expanded access programs for the drug.
This decision comes after a comprehensive review of clinical data revealed that the risks associated with OXBRYTA may outweigh the benefits for patients. The data pointed to an increase in vaso-occlusive crises and fatal events, prompting further assessment.
Chief Medical Officer Aida Habtezion emphasized the company's commitment to patient safety, stating, "Our primary concern is for patients who suffer from SCD, which remains a very serious and difficult-to-treat disease with limited treatment options." Pfizer has advised patients currently on OXBRYTA to consult their physicians to discuss alternative treatments and has assured that it will continue to review and investigate the data.
SCD is a genetic blood disorder that causes red blood cells to become misshapen and break down. It can lead to severe pain, organ damage, and reduced life expectancy. OXBRYTA was approved by regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to treat SCD by increasing hemoglobin's affinity for oxygen and reducing red blood cell sickling.
Despite the setback, Pfizer does not expect this withdrawal to impact its financial guidance for the year 2024. The company has informed regulatory authorities of its decision and is keeping patients and healthcare professionals updated on the situation.
The information in this article is based on a press release statement from Pfizer.
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InvestingPro Insights
Pfizer Inc.'s decision to withdraw OXBRYTA® from the market due to safety concerns has underscored the importance of the company's broader financial health and stability. According to InvestingPro data, Pfizer has a market capitalization of $164.11 billion, reflecting its significant presence in the pharmaceutical industry. Despite a revenue decline of 29.65% over the last twelve months as of Q2 2024, the company maintains a robust gross profit margin of 60.16%, illustrating its ability to retain a substantial portion of its sales as gross profit.
InvestingPro Tips highlight that Pfizer has a history of rewarding shareholders, having raised its dividend for 13 consecutive years and maintaining dividend payments for 54 consecutive years. This commitment to returning value to shareholders is further evidenced by its current dividend yield of 5.69%. Additionally, the company's stock is known for low price volatility, which may appeal to investors seeking stability in their portfolios.
For investors seeking more detailed analysis and further InvestingPro Tips, the platform lists an additional 9 tips for Pfizer, available at https://www.investing.com/pro/PFE. These tips provide insights into analysts' expectations, profitability forecasts, and valuation multiples, all of which are crucial for making informed investment decisions in light of recent events affecting the company's product lineup.
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