Regulatory

FDA expands use of eltrombopag to hepatitis C patients

Last Updated: 2012-11-19 15:20:30 -0400 (Reuters Health)

(Reuters) - GlaxoSmithKline Plc said U.S. health regulators have approved its drug eltrombopag for the additional use of treating thrombocytopenia in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy for the liver disease.

Eltrombopag is now the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based hepatitis C therapy due to low platelet counts, the company said.

The U.S. Food and Drug Administration's approval was based on results from two late-stage studies that collectively enrolled 1,521 patients.

The studies showed that eltrombopag in combination with interferon-based therapy improved a patient's chance of achieving a sustained virologic response.

Eltrombopag, developed with Ligand Pharmaceuticals, is approved in 90 countries and is marketed as Promacta in the United States and as Revolade elsewhere.

In the US, eltrombopag is already indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

"We believe that Promacta sales are set to see an uptick with approval in a significant population with unmet medical need," Roth Capital analyst Joseph Pantginis said in a note.

About 3.2 million people in the United States have chronic hepatitis C, the most common blood-borne virus, according to the U.S. Centers for Disease Control and Prevention.