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Novartis announces FDA approval for Jadenu™ to simplify treatment administration for patients with chronic iron overload | ||||||||||||||||
By: PR Newswire Association LLC. - 31 Mar 2015 | Back to overview list |
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EAST HANOVER, N.J., March 30, 2015 /PRNewswire/ -- Novartis announced today that the US Food and Drug Administration (FDA) has approved Jadenu™ (deferasirox) tablets, a new oral formulation of Exjade® (deferasirox) tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years of age and older. Jadenu is the only once-daily oral iron chelator that can be swallowed whole. Experience the interactive Multimedia News Release here http://www.multivu.com/players/English/7440151-novartis-jadenu-fda-approval/ Many patients with myelodysplastic syndromes, sickle cell disease or thalassemia need repeated blood transfusions and consequently, long-term daily chelation therapy. Jadenu oral tablets can be taken in a single step, with or without a light meal, simplifying administration of treatment for chronic iron overload. Exjade is a dispersible tablet that must be mixed in liquid and taken on an empty stomach. Jadenu is approved under accelerated approval based on a reduction of liver iron concentrations and serum ferritin levels. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. "Novartis has had a long-term commitment to improving the lives of patients with chronic iron overload," said Bruno Strigini, President, Novartis Oncology. "Exjade transformed iron chelation therapy. We responded to feedback from patients and their physicians, and now Jadenu, by simplifying treatment administration, offers an important new option to help meet these patients' needs." Chronic iron overload is a life-threatening cumulative toxicity that results from blood transfusions required to treat sickle cell disease, myelodysplastic syndromes, thalassemia and other conditions. Chronic iron overload also can occur in patients with NTDT due to increased iron absorption in the stomach and intestines1,2. If left untreated, chronic iron overload can damage the liver and heart3,4. Jadenu contains deferasirox, the same active ingredient that is in Exjade, a medicine that has been used by patients with chronic iron overload for almost 10 years. Exjade currently is the most-prescribed chelator in the United States5. "Jadenu is an exciting development for patients with chronic iron overload who have been eager for alternative treatment options," said Dr. Elliott Vichinsky, Director of Hematology and Oncology at the University of California, San Francisco (UCSF) Benioff Children's Hospital Oakland and Professor, UCSF School of Medicine. "Taking iron chelation therapy every day has sometimes been a challenge for them. The administration of Jadenu oral tablets once a day is simple." Novartis has submitted additional regulatory applications for Jadenu in other countries worldwide. Please visit http://www.pharma.us.novartis.com/info/products/brands/Jadenu.jsp for Jadenu full Prescribing Information. About Jadenu (deferasirox) Tablets for Oral Use It is not known if Jadenu is safe or effective when taken with other iron chelation therapy. Controlled clinical trials of deferasirox in patients with myelodysplastic syndromes (a serious blood disorder) and chronic iron overload due to blood transfusions have not been performed. In the United States, Jadenu is available by prescription only. Important Safety Information about Jadenu (deferasirox) Tablets for Oral Use Jadenu should not be taken by patients with pre-existing severe kidney and liver problems; high-risk myelodysplastic syndromes; advanced cancer; low platelet counts; or an allergy to Jadenu. Since deferasirox has been on the market, there have been reports of serious reactions, sometimes leading to death. Severe blood disorders (including neutropenia, agranulocytosis, worsening anemia and thrombocytopenia), serious allergic reactions (including swelling of the throat), severe skin reactions (including Stevens Johnson syndrome and erythema multiforme), decreased hearing and vision changes have been reported. These serious reactions and deaths have happened most often when deferasirox was taken by elderly patients. The most commonly reported side effects related to deferasirox in clinical trials were nausea, vomiting, diarrhea, stomach pain, increases in kidney laboratory values, and skin rash. Please see full Prescribing Information including Boxed WARNING available at www.jadenu.com. About Exjade (deferasirox) Tablets for Oral Suspension It is not known if deferasirox is safe or effective when taken with other iron chelation therapy. Controlled clinical trials of Exjade in patients with myelodysplastic syndromes (a serious blood disorder) and chronic iron overload due to blood transfusions have not been performed. In the United States, Exjade is available by prescription only. Important Safety Information about Exjade (deferasirox) Tablets for Oral Suspension Exjade should not be taken by patients with pre-existing severe kidney and liver problems; high-risk myelodysplastic syndromes; advanced cancer; low platelet counts; or an allergy to Exjade. Since Exjade has been on the market, there have been reports of serious reactions, sometimes leading to death. Severe blood disorders (including neutropenia, agranulocytosis, worsening anemia and thrombocytopenia), serious allergic reactions (including swelling of the throat), severe skin reactions (including Stevens Johnson syndrome and erythema multiforme), decreased hearing and vision changes have been reported. These serious reactions and deaths have happened most often when Exjade was taken by elderly patients. The most commonly reported side effects related to Exjade in clinical trials were nausea, vomiting, diarrhea, stomach pain, increases in kidney laboratory values, and skin rash. Please see full Prescribing Information including Boxed WARNING available at www.exjade.com. Disclaimer About Novartis Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis. References
Novartis Media Relations
For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis. SOURCE Novartis Pharmaceuticals Corporation |
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Copyright 2015 PR Newswire Association LLC. | Back to overview list |