>>15045737 lb notable

Tembexa was approved on fast-track status last year as a small pox treatment - developed by company Chimerix.

Well, this drug was actually developed in tandem with BARDA. Per Wikipedia, “Biomedical Advanced Research and Development Authority (BARDA) is a U.S. Department of Health and Human Services (HHS) office responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological and nuclear (CBRN) threats, as well as pandemic influenza and emerging diseases.”

Snippet from press release announcing Tembex approval on Chimerix website:

“ Chimerix developed the TEMBEXA oral formulations as medical countermeasures for the treatment of smallpox under an ongoing collaboration with BARDA, part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, under contract number HHSO100201100013C.

TEMBEXA’s approval is based on efficacy data in two lethal orthopoxvirus animal models of human smallpox disease, the rabbitpox model (New Zealand White rabbits infected with rabbitpox virus) and the mousepox model (BALB/c mice infected with ectromelia virus). In the pivotal studies in each model, TEMBEXA treatment resulted in statistically significant survival benefit versus placebo following delayed treatment after animals were infected with a lethal viral dose. The FDA’s ‘Animal Rule’ allows for testing of investigational drugs in animal models to support effectiveness in diseases which are not ethical or feasible to study in humans. The TEMBEXA U.S. Prescribing Information has a BOXED WARNING for increased risk for mortality when used for longer duration; see below for Important Safety Information.”

Among possible side effects listed at the bottom of the release is PERMANENT loss of reproductive capacity in males.