[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 cases in their jurisdiction plus 25% of the number of individuals who face an elevated risk of infection from the virus. The latter percentage includes individuals with HIV or who could benefit from HIV pre-exposure prophylaxis.
The U.S. has already allocated more than 20,000 courses of Tpoxx from the SNS.
Regulators in the EU and UK have also approved Tpoxx for monkeypox.
The U.S. also recently announced plans to provide up to 442,000 doses of the Jynneos vaccine from Bavarian Nordic A/S (OMX:BAVA) to help combat the monkeypox outbreak.
The country also will make 50,000 monkeypox vaccines available for Pride and other events with high numbers of gay men, according to CNBC.
There have been more than 39,000 monkeypox cases reported internationally.
In early August, the FDA authorized emergency use of the Jynneos monkeypox vaccine. The EUA covered the intradermal use of the vaccine in individuals with an elevated risk of infection from the virus.
The FDA concluded that the intradermal administration of the two-dose vaccine allows a fraction of the vaccine to be used rather than subcutaneously.