Smallpox Therapy Tembexa Approved by FDA

On Friday, the United States Food and Drug Administration announced their approval for Tembexa (brincidofovir), a smallpox therapy taken as a tablet and oral suspension for both adult and pediatric patients.

The therapy was developed by Chimerix, a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases.

The company created Tembexa oral formulations as medical countermeasures for the treatment of smallpox under an ongoing collaboration and contract with the Biomedical Advanced Research and Development Authority (BARDA), which is a part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

The FDA made their decision based on efficacy data in two lethal orthopoxvirus animal models of human smallpox disease. The first model was a rabbitpox model, while the second was a mousepox model.

The studies for each model showed that treatment with the therapy resulted in a statistically significant survival benefit in comparison to a placebo, following delayed treatment after animals were infected with a lethal viral dose.

The FDA also based their decision on safety information which was derived from clinical trials of Tembexa for a non-smallpox indication, primarily from patients who received hematopoietic stem cell transplants.

The therapy received priority review, fast track and orphan drug designations.

“We are delighted to report our first FDA approved products for the treatment of smallpox, particularly as the importance of pandemic preparedness has been put into focus over the last year,” Mike Sherman, Chief Executive Officer of Chimerix said. “With this approval in hand, we now look forward to advancing our discussions with the Biomedical Advanced Research and Development Authority (BARDA) toward a procurement contract to support national preparedness.”