The positive CHMP opinion was based on five studies evaluating the safety and efficacy of Nplate in children with ITP, including four completed studies (a Phase 3, a Phase 1/2 placebo-controlled study, and two long-term safety and efficacy studies) and one ongoing long-term safety and efficacy study.
The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
Nplate is a thrombopoietin receptor agonist indicated for the treatment of low blood platelet counts in adults with chronic ITP, who had an insufficient response to other medicines or surgery. Nplate mimics the body's natural thrombopoietin and is designed to increase platelet counts in patients with chronic ITP.
In the EU, Nplate is indicated for the treatment of adult chronic ITP patients who are refractory to other treatments (e.g., corticosteroids, immunoglobulins).
Amgen discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.
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