16th Jun 2023 07:42
GSK PLC - Brentford, England-based pharmaceutical company - Says US Food & Drug Administration has extended the review period of the new drug application for momelotinib by three months. Extension aims to provide time to review recently submitted data. The extended action date is September 16. Momelotinib uses "novel mechanism of action" to treat myelofibrosis, a rare blood cancer, as well as progressive anaemia which characterises the disease. Myelofibrosis affects approximately 25,000 US patients. The drug is not currently approved in any markets. GSK says it is "confident in the momelotinib NDA and looks forward to working with the FDA as they finalise their review."
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By Emma Curzon, Alliance News reporter
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