LONDON (dpa-AFX) - GSK plc (GSK, GSK.L) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Exdensur (depemokimab) for the treatment of bronchial asthma (limited to severe or refractory patients whose symptoms cannot be controlled with existing therapies) and CRSwNP (for patients inadequately controlled with standard treatment).
The approval is supported by data from the SWIFT and ANCHOR phase III trials, which demonstrated sustained efficacy with just two doses per year compared with placebo.
This marks the third regulatory approval for depemokimab, following authorisations from the US Food and Drug Administration (FDA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The medicine also recently received a positive CHMP opinion in the EU and remains under regulatory review in other countries, including China.
GSK closed Monday's regular trading at $49.02, down $0.61 or 1.23%. In overnight trading later that evening at 11:20 PM EST, the stock rose to $49.42, an increase of $0.40 or 0.82%.
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