[Monkeypox images from CDC]
The Administration for Strategic Preparedness and Response (ASPR) will make 50,000 courses of the small-molecule drug Tpoxx (tecovirimat) from SIGA Technologies (Nasdaq: SIGA) available to help fight the monkeypox outbreak.There have been 13,517 confirmed monkeypox/orthopoxvirus cases in the U.S. to date, according to the CDC.
In 2018, Tpoxx became the first drug to win an FDA indication for smallpox.
The agency approved the drug under its Animal Rule for treating smallpox using animal efficacy data and human safety data.
The FDA has authorized the use of Tpoxx to treat monkeypox patients through expanded access protocols.
The U.S. maintains a substantial inventory of the drug as part of the Strategic National Stockpile (SNS).
An announcement from the White House noted that it would allocate courses of Tpoxx with a formula based 75% on the number of…