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Amgen's (AMGN) Phase III Study Results on Nplate Published

Amgen Inc. AMGN announced that results from a randomized, double-blind, placebo-controlled phase III study on Nplate (romiplostim) in children with symptomatic immune thrombocytopenia (ITP) were published in The Lancet.

Results showed that children when treated with Nplate witnessed a significant increase (52%) in durable platelet response compared to that observed in the placebo arm (10%), thereby meeting the primary endpoint of the study. In addition, Nplate increased rates of overall platelet response and children who responded to Nplate maintained a consistently elevated platelet count.

Moreover, the overall safety profile that was observed in the Nplate arm was found to be similar to the known safety profile of Nplate.

Amgen intends to seek approval for Nplate for the treatment of pediatric patients. Once approved, it may provide a treatment option to children suffering from symptomatic ITP of more than six months in duration.

As per information provided by the company, ITP is a rare autoimmune disease characterized by a low platelet count in the blood and is estimated to affect on an average 5 in 1,000 children in the U.S. each year.

We note that Nplate is already approved for the treatment of low blood platelet count in adults with chronic ITP, who had an insufficient response to other medicines or surgery. The drug recorded sales of $525 million in 2015, reflecting an increase of 12%.

Additionally, Nplate is being evaluated for the treatment of children aged 12 months to 18 years with chemotherapy-induced thrombocytopenia. Label expansion would boost the drug’s commercial potential.

Other approved products for ITP treatment include Novartis AG’s NVS Promacta/Revolade.

Amgen is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK and Emergent BioSolutions, Inc. EBS, both sporting a Zacks Rank #1 (Strong Buy).

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