Amgen awarded the US FDA approval for Nplate (Romiplostim) for the treatment of immune thrombocytopenia in paediatric patients.
M2 EQUITYBITES-December 17, 2018-Amgen awarded the US FDA approval for Nplate (Romiplostim) for the treatment of immune thrombocytopenia in paediatric patients
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Human therapeutics company Amgen (NASDAQ:AMGN) revealed on Friday the receipt of the US Food and Drug Administration (FDA) supplemental Biologics License Application (sBLA) for Nplate (romiplostim) for the treatment of paediatric immune thrombocytopenia (ITP).
ITP is a rare, serious autoimmune disease characterised by low platelet counts in the blood (a condition known as thrombocytopenia) and impaired platelet production.
The company said the US FDA approved the supplemental Biologics License Application (sBLA) for Nplate (romiplostim) for the treatment of pediatric patients one year of age and older with immune thrombocytopenia (ITP) for at least six months who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
This US FDA approval was based on the company's two placebo-controlled studies - Phase 3 and Phase 1/2 - evaluating the safety and efficacy of Nplate in paediatric patients. In the Phase 3 study, published in The Lancet, rates of overall platelet response were increased with the Nplate group (71%) compared with placebo (20%). In the two placebo-controlled trials, adverse reactions with an incidence of > 25% in the Nplate arm were contusion, upper respiratory tract infection and oropharyngeal pain.
According to the company, Nplate is a thrombopoietin (TPO) receptor agonist that mimics the body's natural TPO and is designed to increase platelet counts in patients with chronic immune thrombocytopenia (ITP). Nplate is approved in 67 countries, including Canada, Australia and Japan.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Dec 17, 2018|
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