Merck & Co, GlaxoSmithKline and Astellas are among the beneficiaries in the latest list of approvals from Japan's Ministry of Health, Labour and Welfare.
The MHLW has approved Merck's human papillomavirus vaccine Gardasil for the prevention of cervical cancer and genital warts and the drug will now go up against GSK's Cervarix, which was approved in Japan in 2009. The US major was also boosted by the thumbs-up for Zolinza (vorinostat), for the treatment of cutaneous T-cell lymphomas, which will be promoted by Taiho Pharmaceutical Co, and for Cubicin (daptomycin), an antibacterial with activity against methicillin-resistant Staphylococcus aureus (MRSA), which was developed by Cubist Pharmaceuticals.
Astellas announced that Betanis (mirabegron) has been granted Japanese marketing approval for the indication of urgency, urinary frequency, and urge urinary incontinence associated with overactive bladder. Filings in Europe and the USA are expected soon.
There were also approvals for GSK's oral vaccine Rotarix to prevent rotavirus gastroenteritis in infants, making it the first vaccine to be available in the country to protect against the virus. Expanded approval was also granted for Lamictal (lamotrigine) for the prevention of depressive episodes in adults with bipolar disorder, another first. Lamictal is currently licensed in Japan as an adjunctive therapy for epileptic seizures in patients inadequately controlled by other antiepileptics.
Philippe Fauchet, president of GSK Japan, noted that since 2009, the company has received approval for 24 products in Japan, including eight new chemical entities.
As reported elsewhere by PharmaTimes World News, the MHLW has also approved AstraZeneca's antiulcerant Nexium (esomeprazole) and Novartis' chronic obstructive pulmonary disease drug Onbrez (indacaterol).