FDA Accepts sNDA for Avatrombopag's Use in Chronic Immune Thrombocytopenia

The FDA has accepted Dova Pharmaceutical’s supplemental New Drug Application (sNDA) for avatrombopag (Doptelet) for the treatment of chronic immune thrombocytopenia (ITP) in patients who have had an insufficient response to a previous treatment, according to a press release.

Avatrombopag was initially approved by the FDA in May 2018 for the treatment of thrombocytopenia in adults with chronic liver disease (CLD) who are scheduled to undergo a procedure, making it the first drug for this indication.

According to Dova, avatrombopag is an orally-administered thrombopoietin receptor agonist (TPO-RA) designed to mimic the effects of TPO, the primary regulator of normal platelet production.

The sNDA acceptance is based on data from a phase 3 clinical trial evaluating the safety and efficacy of avatrombopag for use in this indication. According to the data, the study met its primary endpoint with the number of weeks with a platelet count ≥50x10⁹/L in the absence of rescue therapy and first secondary endpoint of the proportion of patients with platelet counts ≥50x10⁹/L on day 8 with high statistical significance.

Additional supportive efficacy data for the ITP sNDA are provided by 2 phase 3 ITP clinical trials, as well as the 2 phase 3 trials for the treatment of thrombocytopenia in patients with CLD, according to Dova.

“Chronic ITP affects approximately 60,000 adults in the United States and despite currently available therapies, which include 2 other TPO-RAs, there remains an important unmet need,” Lee F. Allen, MD, PhD, chief medical officer of Dova, said in a press release. “Acceptance of this sNDA is another significant milestone for Dova, and an important step towards addressing this underserved patient population and expanding the applications for Doptelet as a treatment for thrombocytopenia. We look forward to working closely with the FDA as they review this sNDA.”

The most common adverse effects associated with avatrombopag include pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.

The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision on the sNDA is June 30, 2019, according to the release.

Reference

Dova Pharmaceuticals Announces FDA Acceptance of Supplemental New Drug Application for Doptelet (Avatrombopag) for the Treatment of Chronic Immune Thrombocytopenia (ITP) [news release]. Dova’s website. http://investors.dova.com/news-releases/news-release-details/dova-pharmaceuticals-announces-fda-acceptance-supplemental-new. Accessed November 7, 2018.