This article is more than 5 years old. Information may no longer be current.
FDA approves Promacta for patients with chronic HCV, thrombocytopenia
Click Here to Manage Email Alerts
The FDA has approved the use of Promacta to treat thrombocytopenia in patients with chronic hepatitis C, according to a press release.
The drug (eltrombopag, Ligand Pharmaceuticals Inc., GlaxoSmithKline), is intended for use in patients who are ineligible for or nonresponsive to interferon-based treatments because of low blood platelet counts. These patients are more likely to experience sustained virologic response or viral cure when taking Promacta in addition to interferon-based therapy, according to the release.
Approval for the new indication stemmed from favorable results of two phase 3, multicenter, double-blind, placebo-controlled studies involving 1,521 patients with low platelet counts. The studies evaluated the use of Promacta with pegylated interferon alfa-2a with ribavirin and pegylated interferon alfa-2b with ribavirin, respectively.
The drug is not intended as a method of normalizing platelet counts, and should only be administered to patients with chronic hepatitis C with thrombocytopenia severe enough to prevent the use of interferon treatment, or to impact the ability to maintain optimal therapy with interferon. Also, the safety and efficacy of Promacta when used in combination with direct-acting agents treating chronic HCV genotype 1 has not been determined, according to the release.
“This is a tremendous achievement for this field of medicine,” John Higgins, president and CEO of Ligand Pharmaceuticals, said in the release. “Very sick patients, who had little to no therapeutic options, will now have an opportunity to potentially receive treatment for hepatitis C. We are extremely pleased with the decision by the FDA, and look forward to the near-term launch of Promacta for this important new indication.”
Promacta can cause hepatotoxicity and can increase the risk for decompensation in patients with chronic HCV. Physicians should regularly monitor ALT and bilirubin levels in patients receiving the drug, according to Ligand Pharmaceuticals. Thrombotic and thromboembolic events also can occur as a result of increased platelet counts following treatment. Adverse events observed during the two clinical trials included anemia, pyrexia, fatigue, headache, nausea and diarrhea.