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news.Following the FDA approval of Critical Therapeutics' supplemental new drug application for Zyflo at the end of September, the company has launched the drug for the treatment of asthma in patients 12 years and older.
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Zyflo is the only drug in the class of 5-lipoxygenase (5-LO) inhibitors approved for marketing by the FDA. The drug interrupts the 5-LO cascade, the products of which trigger the migration and activation of neutrophils and eosinophils, two key white blood cells that contribute to the symptoms of patients with severe persistent or difficult to treat asthma.
“According to the American Lung Association, more than half of the estimated 20 million asthma patients in the US do not have their asthma under control despite existing guidelines for the diagnosis and management of the disease,” Dr Paul Rubin, president and CEO of Critical Therapeutics. “We believe Zyflo represents a safe and effective treatment option for some of these patients.”