Dova Pharmaceuticals Launching Avatrombopag for Chronic Immune Thrombocytopenia

With the FDA approval of a supplemental New Drug Application (sNDA) expanding the use of avatrombopag (Doptelet) for patients with chronic immune thrombocytopenia (ITP), Dova Pharmaceuticals said recently it will begin marketing the drug for the new indication in the middle of July.

The approval of avatrombopag is intended for adult patients with ITP who did not have a significant response to a previous treatment as well as adult patients with chronic liver disease who are undergoing a procedure. Also, the new treatment is administered orally and therefore limits strict dietary restrictions for patients.

“Dova is pleased to provide Doptelet to patients and physicians in the United States for the treatment of chronic ITP in adult patients who have had an insufficient response to a previous treatment,” David Zaccardelli, PharmD, Dova’s president and chief executive officer, stated. “In addition to offering patients with ITP a new treatment option, we expect DOPTELET will also address an important unmet medical need in the market.”

The phase 3 study results lead to the approval. Those on the new drug had platelet counts of at least 50,000 per µL at day 8 of treatment. Furthermore, throughout the 6-month treatment period, avatrombopag was found to be more effective than the placebo in maintaining platelet counts. This data, along with the 24 other studies in the avatrombopag clinical development program, demonstrated the safety and efficacy of the treatment.

“ITP patients should work with their clinician to choose a therapy that supports their lifestyle and aims to achieve the best possible result to treat their ITP. That’s why having additional treatment options are so important,” said Caroline Kruse, president and chief executive officer of the Platelet Disorder Support Association. “We are thrilled to have a new, oral TPO-RA available for adult patients with ITP. Every new treatment provides more choices and new hope to our community.”

In the future Zaccardelli anticipates that avatrombopag may also be effective in treating chemotherapy-induced thrombocytopenia, as phase 3 trial results will be available in 2020.