More Japanese drug OKs: GSK's Rotarix and Lamictal; Takeda's Liovel and new use for Eisai/Abbott's Humira

In a flurry of Japanese drug approvals over the last few days (see also The Pharma Letters July 1 and 4), UK pharma giant GlaxoSmithKline (LSE: GSK) gained clearance for its rotavirus vaccine from Japan’s Ministry of Health, Labor and Welfare (MHLW) for use in infants to prevent gastroenteritis caused by rotavirus.

Rotarix is the first vaccine against rotavirus to be approved in Japan, and the third GSK vaccine to gain approval there following the licences received for Cervarix in 2009 and Arepanrix in 2010. It is expected to be available in Japan towards the end of the year, following the completion of national testing, the drugmaker stated.

GSK also 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.