Amidst fears of the virus being used as a biological weapon, tecovirimat seeks to be the first approved smallpox therapy.
SIGA Technologies, Inc., announced today that it submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its smallpox therapy tecovirimat (TPOXX).
It is also seeking indications for tecovirimat to treat other orthopoxvirus infections. The oral formula has received funding from the United States's Biomedical Advanced Research and Development Authority (BARDA). There currently is no cure for the deadly infection, and if approved, tecovirimat would be the first available therapy.
Despite naturally occurring smallpox being wiped out in the 1970s and early 1980s due to immunization, samples of the virus have been kept for research, and a fear of the infection being used a biological agent in warfare has raised concerns about the lack of an existing treatment.
As a result, BARDA has requested 2 million courses of the therapy for the United States’ Strategic National Stockpile.
“We are very pleased to have achieved this important milestone in the development of TPOXX. If approved, TPOXX would be the first-ever treatment for smallpox,” Phil Gomez, PhD, the chief executive officer of SIGA Technologies, Inc, said in a statement. “Based on extensive positive efficacy data in animal studies and human clinical safety data without any drug-related Serious Adverse Events, we believe the NDA for oral TPOXX is well positioned for favorable, expedited review by the FDA. This is an important milestone not only for SIGA but an important example of how public-private partnerships can advance novel drugs for unmet medical needs towards FDA licensure. This NDA filing is also an important step in advancing health security against the growing threat of a potential smallpox-based bioterror attack.”
SIGA is anticipating an acceptance date in February 2018 for the NDA. The company has requested an expedited review of the NDA, asking the therapy to receive designation for priority review due to the nature of the condition it treats.
Tecovirimat was developed under the FDA’s “Animal Rule,” which allows for the efficacy of a therapy to be evaluated in animal trials, utilizing human clinical trials only to determine safety and dosing regimens. Thus far, no drug-related serious adverse events have been reported with tecovirimat.
A Prescription Drug User Fee Act (PDUFA) date would be expected in 2018, pending acceptance of the NDA. An intravenous formulation of the therapy is also being produced.
A press release was made available.