Pfizer in a statement released on Wednesday said it has received an approvable letter from FDA for its antiretroviral drug maraviroc (Celsentri), the Wall Street Journal reports. According to the Journal, an approvable letter means that FDA believes the drug is worth approving but needs additional information before doing so. The company is in discussions with the agency to address outstanding questions and finalize the product labeling as soon as possible, according to the statement (Corbett Dooren/Johnson, Wall Street Journal, 6/21).
An FDA panel of outside experts in April unanimously recommended that the agency approve maraviroc. Pfizer has proposed using the drug to treat people with advanced HIV or AIDS who have not responded to other medications. Maraviroc works by blocking a protein, called CCR5, on human immune system cells that HIV uses as a portal to enter and infect the cell. Pfizer plans to offer the drug with a test developed by Monogram Biosciences that determines if people likely will respond to the treatment.
FDA in April raised concerns that maraviroc could be associated with an increased risk of liver damage, lymphoma and infections. According to FDA, other CCR5 inhibitors under development have been shown to increase safety risk issues. Pfizer said its studies have shown that maraviroc has no significant effect on the heart and did not increase the incidence of liver problems, cancer or infection compared with other HIV/AIDS drugs.
Continue reading from this report via Kaiser's Daily HIV/AIDS Report here.
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