Novartis has received regulatory approval in Japan for its multiple sclerosis pill Gilenya.
The country’s Ministry of Health, Labor and Welfare has backed once-daily Gilenya (fingolimod) for the prevention of relapse and delay of progression of physical disability in adults with MS. The drug, which is licensed from Japan’s Mitsubishi Tanabe Pharma Corp, is the first in a new class of drugs that modulates sphingosine 1-phosphate receptors. It has now been approved in more than 50 countries, including the USA and European nations.
Novartis noted that the approval is “based on the largest clinical trial programme submitted to date for a new MS drug, including Phase II data in Japan”. Approximately 14,000 MS patients are registered in Japan and until now, there has been only interferon beta as an approved treatment for prevention of relapse in patients with MS.
Green light for Ilaris
The MHLW has also approved Novartis’ Ilaris (canakinumab) for cryopyrin-associated periodic syndrome (CAPS). The green light , which includes all CAPS disease phenotypes, including Muckle-Wells syndrome, was based in part on a local clinical study involving 19 patients and it comprised data from both non-Japanese and Japanese CAPS patients.
Canakinumab, a fully human monoclonal antibody that binds selectively to interleukin-1 beta, is also being studied in juvenile idiopathic arthritis, gouty arthritis and secondary prevention of cardiovascular events.
OK for AstraZeneca’s Faslodex
Meantime, AstraZeneca’s breast cancer drug Faslodex (fulvestrant) 500mg has received regulatory approval in Japan.
Specifically, the drug has been approved for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer which has recurred or progressed following prior endocrine therapy. Tony Zook, head of AstraZeneca’s global commercial organisation, said: “We are very pleased to bring this important and well established medicine for the first time to doctors and their patients in Japan, our second largest market”.
In Japan, it is estimated that annually 10,000 women with metastatic breast cancer will have their cancer recurring or progressing post-endocrine therapy. AstraZeneca plans to launch the drug in the country by the end of the year.
Asahi Kasei osteoporosis drug
Asahi Kasei Pharma also revealed that it has received Japanese approval of a subcutaneous injection formulation of Teribone (teriparatide), known elsewhere as Eli Lilly’s Forteo, to treat osteoporosis with high risk of fracture.
A Phase III clinical trial in Japan demonstrated that, with weekly subcutaneous injections for 72 weeks, Teribone decreased the risk of developing new vertebral fracture by 78.6% compared to placebo. In Japan, it is estimated that more than 11 million people suffer from osteoporosis.
