FDA Approves New Drug Against Weaponized Smallpox
The FDA has approved a new drug to treat smallpox. Fearful of a possible bioweapon attack, the United States has been steadily preparing a defense through BARDA, the Biomedical Advanced Research and Development Authority.
Tecovirimat was the first drug for smallpox, approved in 2018. The FDA granted the new drug, brincidofovir, or BCV, fast track status and orphan drug designations in 2018. The new approval came under the FDA’s Animal Rule.
Drug testing usually goes through several phases prior to approval. First, there is preclinical testing in test tubes and animal models. Phase I is the “first in human” testing, looking primarily for safety and toxicity. Phase II is where researchers look for the best dose to treat a specific condition. The drug being tested is generally given to people who are relatively healthy otherwise.
That’s one reason brincidofovir is important, Gronvall says. In the event of a smallpox attack, “if you are not able to give somebody a vaccine within a few days of exposure, they’re not going to benefit from the vaccine. So, having a treatment is important.”
Gronvall concluded: “It’s another success for BARDA that, with not as much resources [due to COVID-19], they were able … to get this approved. That should be something we think about more in the future, especially with new advances in vaccine technologies and how that could be applied to some of the bioterrorism agents.”
In biodefense labs, she added, “There are populations of people who actually do work with some of these agents and some of these vaccines would be very helpful for them. And so maybe I’m hopeful that … BARDA can take this up.”