GlaxoSmithKline (GSK) announced that the FDA has approved an additional indication for Promacta (EU trade name: Revolade). The FDA approved the product for the treatment of severe aplastic anemia (SAA) in patients who did not show adequate response to immunosuppressive therapy.
SAA is a rare blood disorder which can lead to life-threatening infections or bleeding. According to American Cancer Society, approximately 300 to 600 new cases of SAA are diagnosed annually in the U.S. Current treatment options for SAA patients include immunosuppressive therapy and hematopoietic stem cell transplantation.
However, several patients do not respond to or relapse on immunosuppressive therapy. As per the company press release, there is no established standard of care for SAA patients who do not show adequate response to immunosuppressive therapy or are ineligible for hematopoietic stem cell transplantation thus highlighting the need for newer therapies. Promacta should gain market share in the SAA indication.
We note that Promacta is already approved for the treatment of thrombocytopenia in patients suffering from chronic immune (idiopathic) thrombocytopenia (ITP.TO). The drug is also approved for the treatment of thrombocytopenia in patients with chronic hepatitis C virus (:HCV) infection. Promacta sales increased 33% from the year-ago quarter to £103 million in the first half of 2014.
Glaxo has a research collaboration agreement with Ligand Pharmaceuticals Inc. (LGND) for this drug.