Patients in Japan stand to benefit from the approval of four innovative medicines - Tasigna for the treatment of a life-threatening form of leukaemia, Xolair for severe asthma, Co-Dio for high blood pressure, and Lucentis for wet age-related macular degeneration (AMD), an eye disease that is a major cause of blindness in people over the age of 50 in Japan.
"It is a significant achievement to secure the approval of so many important new medicines for the benefit of Japanese patients in a single day," said Joe Jimenez, CEO of Novartis Pharma AG. "We are proud to be able to offer these innovative medications that provide new options to treat serious, and in some cases life-threatening diseases affecting millions of Japanese patients and their families."
Tasigna (nilotinib) is approved in Japan for the treatment of certain forms of Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML), a rare and potentially fatal cancer of the white blood cells, in adult patients who are resistant to Glivec/Gleevec (imatinib).
The approval was supported by two studies investigating efficacy in different phases of the disease. In an international phase II study, 42 per cent of patients in the chronic phase of CML achieved a major cytogenetic response, while 66 per cent of patients in CML accelerated phase achieved a haematological response. In the Japanese study the percentages were 94 per cent and 71 per cent respectively. Cytogenetic response refers to reduction or elimination of the abnormal Ph+ chromosome, while haematological response involves normalization of patients' white blood cell counts. Japan is currently taking part in a multinational study to explore the potential of Tasigna in newly-diagnosed CML patients.
Xolair (omalizumab) offers an entirely new approach to the treatment of severe asthma by targeting the immunoglobulin E (IgE) antibody, a root cause of allergic disease. It is approved in Japan for treating severe bronchial asthma in adult patients who are uncontrolled despite use of standard medications. Xolair is manufactured by Novartis Pharma AG. In the US, it is co-promoted by Novartis Pharmaceuticals Corporation and Genentech, Inc.
An estimated four million people suffer from asthma in Japan. Although the number of fatalities is decreasing, it is estimated that about 2,500 people die of the disease in Japan each year. The filing was supported by data from a Japanese clinical study showing an improvement in lung function and control of asthma symptoms in patients treated with Xolair.
Co-Dio is a single-pill combination of Diovan (valsartan), the world's leading branded high blood pressure medication, and hydrochlorothiazide (HCT), another high blood pressure treatment from the diuretics drug class. It is approved in Japan as second-line therapy at a dosage of 80 mg valsartan combined with either 6.25 or 12.5 mg HCT.
High blood pressure affects an estimated 40 million people in Japan - nearly a third of the population - and with a majority of patients not reaching their blood pressure treatment goal, there is a growing need for effective single-pill combination therapies. Approval was based on a multi-centre clinical trial in Japanese patients demonstrating superior blood pressure lowering efficacy compared to monotherapy with good tolerability in patients with mild-to-moderate high blood pressure.
Lucentis (ranibizumab) was developed specifically for use in the eye and is the only approved therapy shown to improve vision and vision-related function in a vast majority of patients with wet AMD. Lucentis is indicated in Japan for subfoveal wet AMD, a condition for which an estimated 20,000 people in Japan sought treatment in 2007.
The application was supported by a clinical study in Japan showing that Lucentis enabled patients to improve their vision significantly compared to before treatment. Lucentis, an anti-VEGF (vascular endothelial growth factor) therapy, is developed in collaboration with Genentech and is marketed by Novartis in all countries except the USA.
In addition, an application for the approval of Rasilez (aliskiren) tablets for the treatment of high blood pressure was submitted to the Japanese health authorities in February 2008.
Novartis Pharma K.K. is a Japanese affiliate of Novartis AG, Switzerland.