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Amgen's Nplate wins expanded US FDA approval for newly diagnosed patients

Amgen Inc. said the U.S. Food and Drug Administration expanded approval for its drug Nplate to treat newly diagnosed adults with a rare bleeding disorder called immune thrombocytopenia.

Nplate is now approved to treat newly diagnosed and persistent adult immune thrombocytopenia, or ITP, patients who have had an insufficient response to corticosteroids, immunoglobulins or surgery to remove the spleen.

ITP is an autoimmune disease that is characterized by low platelet counts in the blood and impaired platelet production. The disorder can lead to easy or excessive bruising and bleeding.

The estimated prevalence of the disease in the U.S. is 6.1 per 100,000 adults annually, and about 20,000 new patients are diagnosed each year, Amgen noted in its Oct. 18 press release.

Nplate, or romiplostim, was previously approved by the FDA to treat adults and children one year of age and older with ITP for at least six months who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

The Thousand Oaks, Calif.-based biotech said the expanded approval is based on results from a mid-stage study, which showed that 93% of the patients achieved a higher platelet count during the 12-month period. Additionally, 32% of the patients maintained a higher platelet count for at least six months without taking any medication for immune thrombocytopenia.

The total sales for Nplate amounted to $201 million during the second quarter of 2019, an increase of 12% from the previous year period.