New US approval for Novartis' Promacta

Promacta (eltrombopag), a drug from Swiss pharma giant Novartis (NOVN: VX) that is marketed as Revolade in most countries outside the USA, has had its label expanded by the US Food and Drug Administration (FDA).

The FDA has previously approved Promacta for thrombocytopenia in adults with chronic immune thrombocytopenic purpura who have had an inadequate response or are intolerant to other treatments, and for severe aplastic anemia (SAA) patients who have had insufficient response to standard immunosuppressive therapy (IST).

It has now been approved to treat first-line adults and pediatric patients with SAA in combination with IST.