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| |  ACCOLATE, First New Class of Asthma Drug in 20 Years Cleared by FDA WILMINGTON, Del., Sept. 26, 1996 -- Zeneca Inc. today announced that the United States Food and Drug Administration has cleared ACCOLATE(R) (zafirlukast) tablets, an oral medication, for the preventative and chronic treatment of asthma in adults and children 12 years of age and older. ACCOLATE is the first leukotriene receptor antagonist, a new class of drugs, to receive FDA clearance. It has been over 20 years since a new class of asthma medications has been introduced in the US. ACCOLATE is different from all other types of medications currently being used to treat asthma in the US. More than 12 million Americans suffer from asthma, and worldwide more than 100 million people have this chronic lung disease. Asthma prevalence and deaths have been on the rise. In the United States, asthma accounts for nearly 32 million physician office visits each year and almost one percent of all health care expenses. Asthma symptoms are often debilitating, sometimes life-threatening, and can include wheezing, coughing, a feeling of pressure in the chest, and in extreme cases, the inability to breathe. These symptoms can occur at any time, day or night. There is no cure for asthma, but taking ACCOLATE orally twice a day helps patients control their asthma symptoms. "There is a need for new alternative asthma medications," said Jeffrey M. Drazen, MD, Parker B. Francis Professor of Medicine, Harvard Medical School and physician at Brigham and Women's Hospital in Boston and one of the drug's investigators. "Some patients cannot control their asthma effectively with the medications that are currently available. In these patients, the addition of ACCOLATE may provide an effective and generally well-tolerated approach to help control asthma symptoms," he added. ACCOLATE works by blocking the effect of leukotrienes, natural substances in the body that can contribute to asthma symptoms. ACCOLATE has been studied in more than 4,000 people worldwide. In clinical trials in patients with mild to moderate asthma, ACCOLATE was shown to improve lung function and reduce daytime and nighttime asthma symptoms. ACCOLATE has also been shown to reduce the need for inhaled medications that are commonly used to relieve acute symptoms of asthma. ACCOLATE is not a rescue medication and should not be used to treat acute episodes of asthma. US prescribing information lists the most frequently occurring adverse events in trials with ACCOLATE as headache, infection, and nausea. For these adverse events, there was no statistical difference between ACCOLATE and placebo. "Asthma is a condition that affects a broad range of patients, and it can have a significant impact on their everyday lives," Mary Worstell, Executive Director of the Asthma and Allergy Foundation of America in Washington, DC, said. "It is important for patients with asthma to have new therapeutic options that will help them control their asthma symptoms." ACCOLATE is currently available by prescription in Ireland and Finland and will be available by prescription throughout the United States beginning in early November. Zeneca has been conducting research in respiratory disease for more than 10 years and has a number of compounds in development. Zeneca Inc. is a $2.8 billion bioscience business with approximately 6,000 employees in 53 locations in 24 states. Zeneca Inc. is a wholly owned subsidiary of the UK-based Zeneca Group PLC (NYSE: ZEN), a major, $7.5 billion international bioscience business engaged in the research, development, manufacture, and marketing of ethical (prescription) pharmaceutical, agricultural, and specialty products and the supply of health care services.
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