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news.Daiichi Sankyo has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare for approval of CS-8958, a proprietary anti-flu drug.
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CS-8958 is a laninamivir prodrug that is a Long-Acting Neuraminidase Inhibitor. The drug, developed entirely for the Japanese market by Daiichi Sankyo, will be in the form of an inhalant that will directly treat the airways of influenza patients.
Clinical studies to date with adults and children suffering from type A or B influenza viruses have proven CS-8958 to be effective with a single administration.
In non-clinical studies, CS-8958 has also demonstrated its efficacy with the H1N1 and potentially lethal H5N1 (avian influenza) viruses, leading to an expectation for wide-ranging contributions to influenza treatment in the future.
In November 2009, Daiichi Sankyo began a phase III clinical study in Japan on the prophylactic use of CS-8958.