Siga Technologies secures Tecovirimat FDA approval for smallpox treatment

Siga Technologies has achieved a significant milestone with the U.S. Food and Drug Administration’s (FDA) approval of its orally administered antiviral drug, TPOXX (tecovirimat), for the treatment of smallpox. This approval marks a critical development in public health preparedness and bioterrorism defense.

Developed in collaboration with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), Tecovirimat is the first drug specifically approved for smallpox treatment since the disease was eradicated in 1980. Despite the eradication, the potential use of smallpox as a bioweapon has necessitated the development of effective countermeasures.

FDA Commissioner Scott Gottlieb highlighted the importance of this approval in the context of bioterrorism, stating, “Today’s approval provides an important milestone in these efforts. This new treatment affords us an additional option should smallpox ever be used as a bioweapon.” He further emphasized that Tecovirimat is the first product to receive a Material Threat Medical Countermeasure priority review voucher, underlining the FDA’s commitment to U.S. preparedness for public health emergencies.

The approval was based on extensive clinical trials involving more than 700 healthy human volunteers, which confirmed that Tecovirimat was safe, with no drug-related serious adverse events reported. Additionally, pivotal trials in non-human primates and rabbits demonstrated that Tecovirimat significantly reduced mortality and viral load in subjects infected with related viruses, showcasing its potential effectiveness.

Dr. Phil Gomez, CEO of SIGA Technologies, praised the public-private partnership model, stating, “TPOXX is proof that public-private partnerships work when the partners are committed to a focused mission.” He noted that the FDA approval of Tecovirimat not only serves as a validation of the therapy but also strengthens the national preparedness strategy against potential smallpox outbreaks.

Initially, Tecovirimat will be available solely through the U.S. government’s Strategic National Stockpile (SNS), highlighting its role as a critical emergency resource. Siga Technologies has also secured a $472 million procurement and development contract with BARDA, which includes the provision of two million courses of Tecovirimat to the SNS, ensuring substantial reserves for emergency use.

The FDA’s approval of Tecovirimat is a pivotal moment in the fight against potential bioterror threats and enhances the U.S. government’s capability to respond to a smallpox outbreak effectively. The collaboration between SIGA Technologies and BARDA is a prime example of how targeted public-private partnerships can lead to significant advancements in public health security.