FDA approves Novartis drug Promacta® for first-line SAA and grants Breakthrough Therapy designation for additional new indication

EAST HANOVER, N.J., Nov. 16, 2018 /PRNewswire/ — Novartis announced today that the US Food and Drug Administration (FDA) has expanded the label fo

Source: www.prnewswire.com

Novartis (NYSE: NVS) has received the US Food and Drug Administration (FDA) approval for its drug Promacta (eltrombopag). The drug is for first-line treatment of severe aplastic anemia (SAA) and Breakthrough Therapy designation for low platelet counts in people exposed to radiation. Promacta, marketed as Revolade in most countries outside the US, is an oral thrombopoietin receptor agonist (TPO-RA) that is already approved for SAA for patients who have had an insufficient response to immunosuppressive therapy (IST). It is also approved for adults and children with chronic immune thrombocytopenia (ITP) who are refractory to other treatments, and for the treatment of thrombocytopenia in patients with chronic hepatitis C virus (HCV) infection.