SIGA Technologies Announces FDA Submission of its New Drug Application for oral TPOXX (tecovirimat) to Treat Smallpox
- Category: Small Molecules
- Published on Monday, 11 December 2017 15:31
- Hits: 536
– Company requests Priority Review of TPOXX NDA –
– If approved, would be the first treatment for deadly smallpox –
NEW YORK, NY, USA I December 11, 2017 I SIGA Technologies, Inc. (SIGA) (OTCMKTS:SIGA), a health security company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the oral formulation of TPOXX® (tecovirimat). TPOXX was developed to treat smallpox, as well as other orthopoxvirus infections. No cure or treatment for smallpox exists. The advanced development of TPOXX has been funded by the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA). Pursuant to a contract with BARDA, SIGA has successfully delivered two million courses of TPOXX to the 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,” said Dr. Phil Gomez, Chief Executive Officer of SIGA Technologies, Inc. “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.”
Based on regulatory review requirements, in light of SIGA’s NDA submission on Friday December 8, 2017, the Company expects in February 2018 to receive notification from the FDA that the filing was accepted for review, confirmation of priority review status, and notification of its final action date. Since TPOXX is designed to treat a serious medical condition for which there is no approved therapy, SIGA has requested expedited review of its application.
TPOXX (tecovirimat) was developed under the FDA “Animal Rule,” in which efficacy endpoints are determined in animal studies, and human clinical studies are conducted to determine safety and confirm dosing. There have been no drug-related Serious Adverse Events (SAEs) during the development of oral TPOXX.
ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®
SIGA Technologies, Inc. is a company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats. The company’s lead product is TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug that targets orthopoxvirus infections. While TPOXX™ is not yet approved as safe and effective by the U.S. Food & Drug Administration, it is a novel small-molecule drug of which 2 million courses have been delivered to the Strategic National Stockpile under Project BioShield. For more information about SIGA, please visit www.siga.com.
Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years. Naturally occurring smallpox was eradicated worldwide by 1980, the result of an unprecedented global immunization campaign. Samples of smallpox virus have been kept for research purposes. This has led to concerns that smallpox could someday be used as a biological warfare agent. No cure or treatment for smallpox exists. A vaccine can prevent smallpox, but the risk of the vaccine's side effects is too high to justify routine vaccination for people at low risk of exposure to the smallpox virus.
SOURCE: SIGA Technologies