Dova Pharmaceuticals announced the submission of a supplemental New Drug Application, sNDAto the U.S. Food and Drug Administration for DOPTELET, avatrombopag, the Company’s second generation, orally administered thrombopoietin receptor agonis, TPO-RA, seeking approval for the treatment of adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The FDA previously granted orphan drug designation to avatrombopag for this indication. DOPTELET was recently approved by the FDA in May 2018 for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. “Following the exciting last few months with the approval and launch of DOPTELET for patients with CLD, Dova continues its forward momentum with the submission of our sNDA for DOPTELET for the treatment of patients with ITP,” said Alex C. Sapir, President and CEO of Dova. “This represents another significant achievement for Dova that has the potential to expand the treatment applications for DOPTELET and validate its use for an additional indication. Despite the availability of two approved TPO receptor agonists for the treatment of chronic ITP, there remains an important unmet medical need.” “Given DOPTELET’s convenient oral route of delivery, combined with its lack of hepatotoxicity or need for strict dietary restrictions with its administration, we believe DOPTELET, if approved by the FDA, is well-differentiated and has the potential to capture a meaningful share of the $1.5 billion global ITP market,” Mr. Sapir added.
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