Promacta (eltrombopag) was co-discovered by SmithKline Beecham, now GlaxoSmithKline (GSK) and Ligand. The GSK-Ligand collaboration began in 1997 to utilize Ligand's expertise and technology to discover small-molecule drugs to control hematopoieses and treat patients with cancer, anemia or platelet deficiencies. The research phase of the collaboration ended in 2001. GSK is responsible for the registration and worldwide marketing of Promacta.
What is Promacta?
Promacta is a once-daily oral medicine that activates the thrombopoietin (TPO) receptor. Activation of the TPO receptor causes platelets to increase, relieving conditions of low platelets known as thrombocytopenia.
Promacta® (eltrombopag) was given accelerated approval by the FDA under the trade name Promacta® in November 2008, for the treatment of chronic ITP in adults who have had an insufficient response to corticosteroids, immunoglobulins or following surgical removal of the spleen. Eltrombopag is authorized for use in all 27 member states of the European Union, as well as India, Australia, Ireland, Japan, Taiwan, Turkey, Singapore, Kuwait, Chile, Russia and Bahrain under the trade name Revolade®. In 2008 Ligand licensed the follow-on thrombopoietin receptor agonist LGD-4665.
Thrombocytopenia
A reduction in platelet count to a level <150,000/μL is the defining characteristic of any type of thrombocytopenia and diagnosis can be confirmed following a routine blood test. Thrombocytopenia occurs in 5% - 10% of all patients hospitalized for any cause. The severity of thrombocytopenia varies. Mild-to-moderate cases may resolve spontaneously without treatment, but severe thrombocytopenia can be associated with significant morbidity and mortality. The cause of thrombocytopenia associated with hepatitis C is multi-factorial: inadequate thrombopoietin production by damaged liver, bone marrow suppression by interferon or viruses (HCV), sequestration of platelets in the spleen, and increased platelet destruction from an associated autoimmune process.
Featured Studies
Promacta is currently being evaluated in two parallel global Phase III studies in HepC. Studies are double blinded, placebo controlled with 750 patients enrolled in each trial in more than 300 sites worldwide. Data is expected to be presented in 4Q 2011. The primary endpoint is SVR at 6 months post antiviral treatment (48-72 weeks):
• ENABLE 1 - peginterferon alfa-2a (PEGASYS) plus ribavirin
• ENABLE 2 - peginterferon alfa-2b (PEG-Intron) plus ribavirin
Ongoing Promacta studies in Clincal Trials Web site.
Promacta Beat
GSK announces changes to the REMS program for PROMACTA®
Transcript: Promacta ENABLE 1 Panel Discussion
ENABLE 1 Abstract (click on "Itinerary Planner" then "search")
Promacta presentation (Dr. Nezam Afdahl)
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