New product developments in Japan for Astellas, Takeda, Otsuka, Daiichi Sankyo and GlaxoSmithKline.
Japan’s Astellas has launched its new drug for castration-resistant prostate cancer – Xtandi (enzalutamide) – in its home market. The product – developed alongside US company Medivation – was first approved in the US in 2012 and in Europe last year, achieving sales of $445m in 2013. As of the end of April, it had been launched in 23 countries worldwide, including the US, Canada, UK, Germany, France, and South Korea.
Takeda has been given a green light by the Ministry of Health, Labor and Welfare (MHLW) for changes to the label of its diabetes therapy Nesina (alogliptin) that should make it much more likely to be prescribed. Nesina had been largely reserved for use when other oral antidiabetic drugs (OADs) – including alpha-glucosidase inhibitors, thiazolidinediones and biguanides – are not sufficiently effective, but can now be used alongside any OAD or insulin in type 2 diabetes. The drug was approved in Japan in 2010 and was given the go-ahead in Europe (as Vipidia) and the US last year.
Otsuka has launched a 30mg tablet formulation of Samsca (tolvaptan), its drug to treat autosomal dominant polycystic kidney disease (ADPKD), which should make the therapy easier for patients to take. The higher-dose formulation adds to Otsuka’s 7.5mg and 15mg strengths that were first approved in Japan earlier this year. Tolvaptan is a first-in-class vasopressin V2-receptor antagonist and is already sold in a number of countries for the treatment of low sodium levels in the blood.
Daiichi Sankyo has had the approved indications for its Ranmark (denosumab) product extended to include giant cell tumours of bone (GCTB). The RANK ligand-targetting drug was originally developed by Amgen and has been approved in Japan since 2012 for the treatment of bone complications stemming from multiple myeloma and bone metastases from solid tumours. It was approved for GCTB in the US last year and is also sold under a different trade name (Pralia) for osteoporosis.
GlaxoSmithKline (GSK) has filed for approval of its long-acting muscarinic antagonist umeclidinium as a once-daily treatment for chronic obstructive pulmonary disease (COPD) in Japan, its first Asian market. The drug has already been approved under the Incruse brand name as a monotherapy – as well as in a combination with long-acting beta agonist (LABA) vilanterol called Anoro – in Europe, the US and Canada.