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ArticleFDA Updates

FDA approves Brincidofovir to treat smallpox

The US FDA has approved Chimerix’s brincidofovir (BCV, Tembexa) to treat smallpox. Fearful of a possible bioweapon attack, the United States has been steadily preparing a defense through the Biomedical Advanced Research and Development Authority. BCV is neither a new nor unknown drug. It is a lipid conjugate of cidofovir, a drug used to treat cytomegalovirus (CMV) in patients with AIDS.

Dose:

  • ≥48 kg (tablet or oral suspension): 200 mg PO qWeek x 2 doses (on Days 1 and 8)
  • <48 kg (oral suspension): 4 mg/kg PO qWeek x 2 doses (on Days 1 and 8)

Adverse Effect: Diarrhea (8%), Nausea (5%), Vomiting (4%), Serum creatinine elevated (>1.5-3x ULN) (4%), Abdominal pain (3%), ALT elevated (>3 to 20x ULN) (2-3%), Total bilirubin elevated (>1.5 to 10x ULN) (1-3%), AST elevated (>3 to 20x ULN) (1-2%)

Tecovirimat was the first drug for smallpox, approved in 2018.

Source: FDA

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