Amgen and FDA Agree to Modify Nplate® (Romiplostim) Risk Evaluation and Mitigation Strategy
"The goals of the Nplate® NEXUS Program were to educate physicians and patients about treatment risks and benefits, and to define the long-term safety profile of Nplate," said
The primary modification of the REMS is the removal of the elements to assure safe use; however, a modified REMS communication plan will remain in place. In addition, the Medication Guide will no longer be part of the REMS, but will be part of approved product labeling.
From 2008 to 2011, the Nplate® NEXUS Program has collected long-term safety data from more than 5,200 patients. The restrictive elements of the REMS included enrollment of prescribers, patients and institutions to assist in collecting long-term safety information. Upon further review, the
About Adult ITP
In patients with immune thrombocytopenia (ITP), platelets - blood elements needed to prevent bleeding - are destroyed by the patient's own immune system. Low platelet counts leave adult ITP patients open to sudden serious bleeding events. The risk for serious bleeding events increases when platelet counts drop to less than 30,000 platelets per microliter; normal counts range from 150,000 to 400,000 platelets per microliter. ITP has historically been considered a disease of platelet destruction although recent data suggest that the body's natural platelet production processes in ITP are also unable to compensate for low levels of platelets in the blood. Increasing the rate of platelet production may address low platelet levels associated with ITP. Currently, there are approximately 90,000 adult chronic ITP patients in
The Nplate FIRST STEP™ Co-Pay Coupon Card Program
Nplate is approved in the U.S.,
Nplate is the first
In the U.S., Nplate is indicated for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts.
In the EU, Nplate is indicated for the treatment of splenectomized adult chronic ITP patients who are refractory to other treatments (e.g., corticosteroids, immunoglobulins). Nplate may be considered as a second-line treatment for adult non-splenectomized ITP patients for whom surgery is contraindicated.
Nplate was named as a recipient of the U.S. Prix Galien 2009 "Best Biotechnology Product" award and also received the 2009 Scrip Awards for "Best New Drug." Nplate has also been honored with numerous awards throughout the EU, including a 2010 Prix Galien in
For more information about Nplate, please visit www.Nplate.com.
Important U.S. Nplate Safety Information
The risks associated with Nplate include progression of MDS to acute myelogenous leukemia (AML) in patients with MDS, thrombotic/thromboembolic complications, bone marrow reticulin formation and risk for bone marrow fibrosis, worsened thrombocytopenia after cessation of Nplate, and lack or loss of response to Nplate. In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction.
Important EU Nplate Safety Information
The most common side effects are headache, fatigue, arthralgia and myalgia.
The risks associated with Nplate include reoccurrence of thrombocytopenia, bleeding after cessation of treatment, increased bone marrow reticulin, thrombotic/thromboembolic complications, progression of existing MDS (in patients with MDS), loss of response to Nplate, and effects on red and white blood cells.
Forward Looking Statements
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