GlaxoSmithKline receives new approval for Rotarix and significant new indication for Lamictal® (lamotrigine) in Japan

GlaxoSmithKline (GSK) today announced that its rotavirus vaccine has received approval in Japan from the Ministry of Health, Labour and Welfare (MHLW) for use in infants to prevent gastroenteritis caused by rotavirus. RotarixTM is the first vaccine against rotavirus to be approved in Japan, and the third GSK vaccine to gain approval in Japan following the licences received for Cervarix® in 2009 and ArepanrixTM in 2010. It is expected to be available in Japan towards the end of the year, following the completion of national testing.

GSK also today gained approval for a significant new indication in Japan for Lamictal® (lamotrigine) Tablets 25mg and 100mg for the prevention of depressive episodes in adult patients with bipolar disorder. Lamotrigine is the first treatment in Japan to be classified for bipolar disorder. It is currently licensed in Japan as an adjunctive therapy for epileptic seizures in patients inadequately controlled by other antiepileptic drugs. It will be available for the new indication immediately.

Philippe Fauchet, President of GlaxoSmithKline Japan, commented: “These two approvals demonstrate the clear progress GSK is making in bringing more products that offer real value to patients in Japan. In total, we have now received 24 new product approvals, including eight new chemical entities, since 2009. We are particularly pleased to contribute to preventative healthcare with the approval of our rotavirus vaccineand we hope this will help to reduce the significant burden of this disease in Japan. In addition, with the new indication for lamotrigine, we now have the first approved treatment for bipolar disorder available in Japan to help prevent depressive episodes in adults with bipolar disorder.”

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