Tecovirimat Well Tolerated for Treatment of Monkeypox
By day 21, 23 of 25 patients had resolution of lesions and pain; none of the patients discontinued treatment
By day 21, 23 of 25 patients had resolution of lesions and pain; none of the patients discontinued treatment
The IV formulation is designed to provide an alternative option for patients who are unable to swallow the oral capsules.
Federal officials were alerted that the vials were found by a laboratory worker while cleaning out a freezer in the facility
Vials were found by a laboratory worker while cleaning out a freezer in a facility that conducts vaccine research
The treatment was approved under the FDA’s Animal Rule which allows findings from animal efficacy studies to determine the approval for a drug when feasible or ethical studies in humans cannot be conducted.
The approval was supported by findings from 12 clinical trials of TPOXX with more than 700 healthy volunteers that showed no drug-related serious adverse events.
Brincidofovir is the Company’s lead candidate, a nucleotide analog that has antiviral activity against variola virus, which causes smallpox.
The Centers for Disease Control and Prevention (CDC) classifies key biological agents into three categories: A, B, and C.
The treatment was developed under the FDA’s ‘Animal Rule’; where efficacy is determined in animal studies and human studies determine safety and appropriate dosing. The FDA have stated a target action date for TPOXX of August 8, 2018.