EU approval for expanded use as a second-line monotherapy for type 2 diabetes patients who cannot take metformin. In 2012, the EC approved the use of Galvus and Eucreas in combination with other diabetes treatments. In 2014, Eucreas (850/50mg and 1000/50mg) was approved in China as a high-dose single-pill combination metformin/DPP-4 inhibitor approved in that country. In April 2015, Galvus monotherapy indication was approved in China. In September 2015, Eucreas was approved in Japan under the name EquMet as a single-pill combination metformin/DPP-4 inhibitor approved in that country. Entresto (sacubitril/valsartan) is an angiotensin receptor/neprilysin inhibitor indicated for the treatment of chronic heart failure with reduced ejection fraction (HFrEF). It acts to improve the protective neurohormonal systems of the heart while simultaneously suppressing the harmful system (renin-angiotensin-aldosterone system). Entresto was approved and launched in the U.S. in July 2015 as a treatment for HFrEF. In September 2015, the Swiss health authority approved Entresto to reduce the risk of cardiovascular mortality and morbidity in patients with HFrEF. In November 2015, Entresto was approved in the EU for the treatment of adult patients with symptomatic HFrEF. Immunology and Dermatology Neoral (cyclosporine, USP Modified) is an immunosuppressant to prevent organ rejection following a kidney, liver, or heart transplant. Neoral is also approved for use in lung transplant in various countries outside of the U.S. This micro-emulsion formulation of cyclosporine is also indicated for treating selected autoimmune disorders, such as psoriasis and rheumatoid arthritis. Neoral is marketed in approximately 100 countries. Myfortic (enteric-coated formulation of mycophenolate sodium) is approved in approximately 90 countries for the prevention of acute rejection of kidney allografts, and is indicated in combination with cyclosporine and corticosteroids. Zortress/Certican (everolimus) is an oral inhibitor of the mTOR pathway, indicated to prevent organ rejection following solid organ transplantation. Under the trade name Certican, it is approved in approximately 90 countries to prevent organ rejection for renal and heart transplant patients; and in 70 countries worldwide to prevent organ rejection for liver transplant patients. In the U.S., under the trade name Zortress, the drug is approved for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant, as well as for the prophylaxis of allograft rejection in adult liver transplant recipients. Everolimus is also available from the company in different dosage strengths and for different uses in non-transplant patient populations under the brand names Afinitor, Afinitor Disperz, and Votubia. Everolimus is also licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents. Ilaris (canakinumab) is a human monoclonal antibody that selectively binds and neutralizes interleukin-1b (IL-1b), a pro-inflammatory cytokine. Ilaris has been approved in approximately 70 countries for the treatment of children and adults suffering from cryopyrin-associated periodic syndromes, a group of rare disorders characterized by chronic recurrent fever, urticaria, occasional arthritis, deafness, and potentially life-threatening amyloidosis. In 2013, Ilaris was approved in the EU for the treatment of acute gouty arthritis in patients who cannot be managed with standard of care; and in the U.S., the EU, and other countries for the treatment of systemic juvenile idiopathic arthritis. The company is also developing Ilaris for hereditary periodic fever syndromes. Xolair (omalizumab) is approved in the EU, Switzerland, and approximately 40 other countries as a treatment for chronic spontaneous urticaria (CSU)/chronic idiopathic urticaria (CIU), including approvals in the EU as add-on therapy for the treatment of CSU in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment; and, in the U.S., for the treatment of adults and adolescents (12 years of age and above) with CIU
novartis ag-sponsored adr (NVS:New York)
Phone: 41 61 324 11 11
Fax: 41 61 324 80 01www.novartis.com
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