Therapy Areas: Inflammatory Diseases
European Agency Grants Amgen Positive Opinion to Expand Use of Nplate in Pediatric Patients With Chronic Immune Thrombocytopenic Purpura
13 November 2017 - - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion to expand the current indication for Thousand Oaks, California-based human therapeutics developer Amgen's (NASDAQ: AMGN) Nplate (romiplostim) to include the treatment of chronic immune (idiopathic) thrombocytopenic purpura for patients one year of age and older who are refractory to other treatments, such as corticosteroids or immunoglobulins, the company said.
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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