nt to or intolerant of hydroxyurea. Jakavi is approved in approximately 95 countries for patients with myelofibrosis, including the EU member states, Japan, Canada, Australia, Mexico, and Argentina. Jakavi is approved for the polycythemia vera indication in 45 countries, including Switzerland, Japan, and Canada. Ruxolitinib, marketed in the U.S. as Jakafi by Incyte Corporation, is approved by FDA for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also approved by the FDA for treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis. Promacta/Revolade (eltrombopag) is a once-daily oral thrombopoietin receptor agonist that works by stimulating bone marrow cells to produce platelets. It is marketed under the brand name Promacta in the U.S. and Revolade in various countries outside the U.S. In the U.S., Promacta is approved for the treatment of thrombocytopenia in adult and pediatric patients one year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. In August 2015, the FDA approved an oral suspension formulation of Promacta that is designed for younger children with chronic ITP who might not be able to swallow tablets. Promacta is also approved for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy, and for the treatment of patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy. Revolade is approved in approximately 100 countries worldwide for the treatment of adult chronic ITP splenectomised patients who are refractory to other treatments (corticosteroids, immunoglobulins). Revolade is also indicated in 45 countries worldwide in adult patients with chronic hepatitis C virus infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy. In September 2015, Revolade was approved by the EC for the treatment of adults with acquired SAA who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for hematopoietic stem cell transplant. Promacta/Revolade is marketed under a collaboration agreement between Ligand Pharmaceuticals, Inc., and the company. Promacta/Revolade was acquired from GlaxoSmithKline plc (GSK). Farydak (panobinostat) is a histone deacetylase inhibitor indicated, in combination with bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received approximately two prior regimens, including bortezomib and an immunomodulatory agent. Farydak in combination with bortezomib and dexamethasone was approved in 2015 in the U.S., the EU, and Japan for certain patients with previously treated multiple myeloma. Odomzo (sonidegib) is a selective smoothened inhibitor approved in the U.S. in July 2015 for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. In addition, the EC approved Odomzo in August 2015 for the treatment of adult patients with laBCC who are not amenable to curative surgery or radiation therapy. Cardio-Metabolic Galvus (vildagliptin), an oral DPP-4 inhibitor, and Eucreas, a vildagliptin and metformin single-pill combination, are indicated for the treatment of type 2 diabetes. Galvus is approved in approximately 130 countries, including the EU member states, Japan (as Equa), and countries in Latin America and Asia-Pacific. Eucreas is a single-pill combination of a DPP-4 inhibitor and metformin approved in Europe, and also under the trade name Galvus Met; and is approved in approximately 125 countries. In 2012, Galvus received
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