Siga Technologies bags Tecovirimat FDA approval for smallpox treatment

Tecovirimat FDA approval : Siga Technologies has bagged the US Food and Drug Administration (FDA) approval for its orally administered antiviral drug TPOXX (tecovirimat) for smallpox treatment.

Siga Technologies had developed the small molecule drug Tecovirimat in conjunction with the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA).

The FDA said that although smallpox had been eradicated in 1980, there has been a major concern that the disease could be used as a bioweapon. Tecovirimat is now the first approved drug for smallpox treatment, said the US regulator.

Commenting on Tecovirimat FDA approval for small pox treatment, FDA Commissioner Scott Gottlieb, said: “To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons. 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.

“This is the first product to be awarded a Material Threat Medical Countermeasure priority review voucher.  Today’s action reflects the FDA’s commitment to ensuring that the U.S. is prepared for any public health emergency with timely, safe and effective medical products.”

Tecovirimat FDA approval for smallpox was driven by data gathered from a dozen clinical trials of the drug in more than 700 healthy human volunteers, which demonstrated no drug-related serious adverse events.

Four pivotal trials in non-human primates (NHPs) and a couple of pivotal trials in rabbits showed that TPOXX (tecovirimat) considerably decreased mortality as well as viral load in NHP infected with monkeypox virus (MPXV) and in rabbits infected with rabbitpox virus.

Dr. Phil Gomez – CEO of SIGA Technologies, commenting on Tecovirimat FDA approval for small pox treatment, said: “TPOXX is proof that public-private partnerships work when the partners are committed to a focused mission.

“The FDA approval of TPOXX achieves an important objective for both SIGA and our lead partner in the U.S. Government, the Biomedical Advanced Research and Development Authority (BARDA).  The approval validates this novel smallpox therapy as an important medical countermeasure in response to a potential smallpox outbreak.”

Siga Technologies said that TPOXX will be initially available only through the US government’s Strategic National Stockpile (SNS). The company has a $472 million procurement and development contract with BARDA, under which two million courses of oral TPOXX have been provided to the SNS.

For more pharma regulatory news like the Tecovirimat FDA approval for small pox treatment, keep following PharmaNewsDaily.com.