Generic Medicine OKd by Europe for Thrombocytopenia With HCV

Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for Eltrombopag Viatris (eltrombopag), a generic medicine for the treatment of children and adults with primary immune thrombocytopenia (ITP), thrombocytopenia associated with chronic hepatitis C virus (HCV) infection, and acquired severe aplastic anemia.

The application by Viatris Limited relied on studies demonstrating the satisfactory quality of Eltrombopag Viatris, and its bioequivalence to the reference product Revolade, which has been authorized in the European Union since March 11, 2010. Revolade (eltrombopag olamine, Novartis Pharmaceuticals UK Ltd) is available as 25mg, 50mg, or 75mg film-coated tablets, or as an oral suspension.

Antihemorrhagic Agent Mimics Natural Signaling

Eltrombopag Viatris will be available as 12.5mg, 25mg, 50mg, and 75mg film-coated tablets. 

The CHMP explained that its active substance, eltrombopag, is an antihemorrhagic that interacts with the transmembrane domain of the human thrombopoietin receptor, triggering signaling cascades that are similar to those triggered by human thrombopoietin. This interaction induces the proliferation and differentiation of bone marrow progenitor cells and thus stimulates platelet production. 

The reference branded product Revolade has been shown to be more effective than placebo in normalizing platelet counts.

Eltrombopag Viatris is indicated for the treatment of:

• Primary ITP in adult patients who are refractory to other treatments such as corticosteroids or immunoglobulins.
• Pediatric patients aged 1 year and above with primary ITP lasting 6 months or longer from diagnosis and who are refractory to other treatments such as corticosteroids or immunoglobulins.
• Thrombocytopenia in adult patients with chronic HCV infection, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy.

The European Medicines Agency said that treatment with Eltrombopag Viatris should be prescribed and supervised by a doctor experienced in the treatment of hematological diseases or the management of chronic hepatitis C and its complications.

The most important serious adverse reactions of the reference product Revolade are hepatotoxicity and thrombotic/thromboembolic events. Common side effects include headache, nausea, diarrhea, abdominal pain, pruritus, arthralgia, myalgia, pyrexia, and fatigue.

Further detailed recommendations will be published in the summary of product characteristics after the marketing authorization has been granted by the European Commission.