Nplate’s Rival Drug Promacta Continues to Wait for FDA Approval

Promacta, a new drug by GlaxoSmithKline continues to wait for approval by the FDA so that it can compete with Amgen’s recently approved Nplate. Last May, the FDA advisory panel voted unanimously in favor of Promacta for short-term treatment and the FDA typically approves what their panels support. The FDA was supposed to make a decision by September 19, 2008 about whether to approve Promacta for the short term use of 6 weeks.

Both Nplate and Promacta treat Idiopathic Thrombocytopenic Purpura (ITP), a condition causing low platelet counts and problems with blood clotting. While Nplate provides long-term treatment for chronic ITP patients, Promacta will be the first to treat it short-term with a once a day oral pill.

Promacta, drug name eltrombopag, is a non-peptide thrombopoietin receptor agonist that stimulates the creation and separation of bone marrow cells that produce blood platelets. Because it is a non-peptide, it is hoped that it will raise platelet counts without suppressing the immune system. Possible side effects may include dry mouth, headache, nausea, flu-like illness, fatigue and chills.

Have you or someone you know experienced side effects from using Nplate? Please share your experiences and opinions about these drugs!