Tecovirimat, brand name TPOXX is currently the only available treatment for monkeypox. While it has only been tested for use against smallpox, its manufacturer SIGA Technologies (SIGA) is now flooded with requests for supplies, as cases in the global monkeypox outbreak continue to rise, and pressures are being placed on stocks of vaccines and treatments.
The company has produced and delivered 360,000 courses of treatment, consisting of 2 pills per day for 14 days, as the US has sought to replenish its stockpile of treatments over the last two years. Presently the stockpile has dropped to just under 2 million doses.
According to SIGA CEO Phil Gomez, only the US and Canada were stockpiling doses. He noted in an interview however that since the outbreak, “We do have a lot of inquiries coming in from dozens of countries that are now trying to catch up and establish stockpiles.”
Currently the company has $56 million in orders for treatment courses this year from 6 different countries and agencies, and estimates about half of those orders will be filled by September.
Gomez added, “We’re certainly working with our network to expand manufacturing, but we were anticipating a large number of orders over the next few years, so we have product available and in our supply chain to advance in response to these orders.”
There are now over 16,000 confirmed cases in 75 countries, and the World Heath Organization just declared a public health emergency globally as cases and deaths continue to rise.
Unfortunately testing, treatments, and vaccines are still limited in availability across the globe. Even despite the stockpile, TPOXX is still difficult to procure due to provider confusion and the complexity of the regulatory process. One additional complexity is that the FDA and CDC require extensive paperwork be filed after use of the drug to help them determine safety data regarding the pills, since technically it is not approved for use in monkeypox cases.
TPOXX is available as both pills and an intravenous suspension. It was approved for use against smallpox in 2018, at which point the US began to stockpile doses. The National Institutes of Allergy and Infectious Diseases (NIAID) will begin clinical trials on the use of drug in monkeypox in the coming months.
Monkeypox cases have been largely spreading among gay males, although technically it is not clear if the disease is spreading through sexual contact, or simply coincidentally through close contact, secondary to sexual contact. Symptoms of infection include fever, muscle aches, chills, and skin lesions.
The virus has long been endemic to Africa, where two specific strains, or clades are circulating. The strain circulating globally is the West African strain, which is the less lethal version of the virus. The Congo Basin clade has a much higher mortality, but it much more rare.
Still countries like Brazil and Spain have reported fatalities, which has raised some concern if the virus could become more virulent over time if it is not contained.
Gomez noted, “Unfortunately, I think the original perception that this was going to be a self-limiting infection with not a lot of morbidity and mortality just hasn’t played out.”
