Posted by Michael Wonder on 07 Feb 2018
SIGA Technologies announces FDA accepts NDA and grants priority review for oral Tpoxx to treat smallpox
7 February 2018 - If approved, Tpoxx would be the first treatment for smallpox.
SIGA Technologies today announced that the U.S. FDA has accepted the company’s new drug application for its oral formulation of Tpoxx (tecovirimat). Tpoxx is a novel small molecule antiviral therapy for smallpox infection. SIGA requested priority review of its Tpoxx application at the time the filing was submitted because smallpox infection is a deadly disease for which no cure or treatment currently exists.
The FDA advised that it has granted priority review to the application, meaning that the agency will target completing its review in six rather than ten months. In light of the submission on 8 December 2017, the FDA has notified SIGA that the agency’s target final action date is 8 August 2018.
