FDA Grants Expanded Use of Promacta for Novartis

Movartis said that the updated label will also include a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets.

Promacta was approved by the FDA as a tablet formulation back in June 2015 for children 6 years of age and older. It was approved back in 2008 for use in adult patients with the same condition.

Indications from the press release show that ITP affects as many as 5 in 100,000 children each year. ITP is characterized by a low platelet count.  Chronic ITP is when there is ongoing disease for more than 12 months after diagnosis. It is also said to occur in 13% to 36% of children with immune thrombocytopenia, and a small number of pediatric patients with chronic ITP are said to be at risk of significant bleeding.

Treatment with Promacta was said to significantly increase and sustain platelet counts among pediatric patients with chronic ITP with an insufficient response to prior chronic ITP therapies. Some patients taking concomitant ITP medications were also said to be able to reduce or discontinue their use of these medications, primarily corticosteroids.

Novartis shares were down almost 3% at $94.71 in New York trading, with its ADSs having a 52-week trading range of $84.17 to $106.84.

Promacta is a once-daily oral thrombopoietin receptor agonist that works by inducing stimulation and differentiation of megakaryocytes from bone marrow stem cells to increase platelet production. Promacta should be used only in those whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.