Novartis won the second breakthrough therapy for the New Year
Novartis won the second breakthrough therapy for the New Year
January 05, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Novartis today announced that the FDA has combined Promacta (eltrombopag) with standard immunosuppressive agents to provide breakthrough therapy as a first-line treatment for severe aplastic anemia (SAA). This is the second breakthrough therapy award that Novartis received this week.
SAA is a rare blood disease. Because the patient's bone marrow is unable to produce enough red blood cells, white blood cells, and platelets, people with this serious illness may experience weakness and complications such as fatigue, difficulty breathing, recurrent infections, and abnormal bruising or bleeding. And may limit their daily activities. As many as one-third of patients do not respond to current treatment or have recurrence of symptoms.
Promacta is a once-a-day oral thrombopoietin (TPO) receptor agonist that increases platelet production by inducing megakaryocyte stimulation and differentiation from bone marrow stem cells. Promacta is marketed in Revolade in countries outside the United States and has been approved for the treatment of thrombocytopenia in adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) in more than 100 countries.
Novartis's analysis of the NIH National Heart, Lung, and Blood Institute (NHLBI) showed that more than half (52%) of untreated SAA patients received Promacta treatment at the same time as standard immunosuppressive therapy, reaching within six months. Complete remission, the overall response rate is as high as 85%.
“Promacta is a promising drug that, if approved for first-line treatment for severe aplastic anemia, may redefine the standard of care for patients with this rare and severe bone marrow disease,†said Samit Hirawat, Head of Global Drug Development, Novartis Oncology The doctor said: "We will continue to work closely with the FDA to provide Promacta to SAA patients who have not received treatment as soon as possible."
The first-line therapy application for the drug in the US and EU is expected to be filed in 2018. We hope that this breakthrough therapy will soon become the first line of SSA therapy to treat more patients with this malignant disease.
Reference materials:
[1] Novartis drug Promacta® receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia (SAA)
[2] Novartis' New Year Continues With Second FDA Breakthrough Tag of the Week
Original title: Mei Kai twice! Novartis won the second breakthrough therapy for the New Year
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