Alternative treatment for monkeypox caught in regulatory delays

Fears of a monkeypox vaccine shortage draw attention to more than a million doses of a smallpox treatment in the strategic national stockpile that experts say could be an effective, but difficult backup to ‘access.

Why is this important: TPOXX (Tecovirimat) is FDA approved to treat smallpox and has been tested in animals with monkeypox, which is a related virus. But because it’s not licensed and classified as an investigational new drug, vendors responding to the outbreak must make requests to the Centers for Disease Control when using it, leading to administrative burdens and delays. .

  • Calls for easier access are growing, with the monkeypox outbreak now spanning all but two states and accounting for 6,326 confirmed cases.
  • Although the CDC waived some requirements, doctors and clinics still have to submit more than a dozen pages of forms, complete follow-up visits and collect patient data.
  • “Some clinics don’t have the administrative capacity to complete paperwork, so they refer patients to other providers…it’s a very variable situation across the United States, and it shouldn’t be the case. “, David Harvey, director of the National Coalition of STD Directors, told Axios.

What we mean: The San Francisco AIDS Foundation, which has a waiting list of 10,000 people for monkeypox vaccines, just started administering the TPOXX treatment after weeks of patient requests.

  • The administrative burden of paperwork, follow-up visits and obtaining patient consent was previously too much to bear with already stretched resources, Tyler TerMeer, CEO of the foundation, told reporters this week.
  • Access issues add to missed diagnoses, inappropriate treatments and other problems for suffering patients trying to navigate an unprepared and understaffed medical system, Kaiser Health News reported.

The context: The TPOXX is one of the countermeasures that the government keeps on hand to protect against possible biological attacks.

  • It falls under CDC regulations for investigational new products. To obtain such a drug for serious or life-threatening conditions, providers must take steps such as scheduling follow-up visits, taking photos, and requiring patients to keep a diary.
  • Even after the CDC eliminated some of these steps, the time it takes to care for patients becomes more onerous as more people seek treatment, Marshall Glesby, associate chief of the infectious diseases division, told Axios. at Weill Cornell Medicine.

Driving the news: Some advocacy organizations and vendors are asking the CDC to release TPOXX from national inventory, freeing it from the regulatory process.

  • “We’re saying remove the barrier completely,” Garrett Wilkinson, policy manager at Partners in Health, told Axios.
  • The treatment could be more readily available if the Biden administration declares a public health emergency or even a significant potential for one, and the FDA grants emergency use authorization, as it has for COVID vaccines. -19.
  • But even if the administration did, “FDA should review the circumstances and the appropriateness of an EUA for a particular medical countermeasure and determine that the criteria for issuing an EUA have been met,” wrote a doorkeeper. -word from the FDA in an e-mail. .

Where are things going: TPOXX is the lead product from SIGA Technologies, which has contracted with the federal government for the past 20 years and has tested the drug in animals infected with other orthopoxviruses, including monkeypox.

  • In 2018, the FDA granted TPOXX approval for use against smallpox.
  • Since the beginning of the monkeypox epidemic at the beginning of the summer, SIGA has also concluded agreements with Canada and countries in Europe and Asia.
  • The company is restocking expired doses in US stock with 363,000 new doses and has the ability to replenish that supply further.
  • “We don’t know where the outbreak (will go), but at the moment we believe we are able to respond” to increased demand, chief executive Phillip Gomez told Axios.

Yes, but: Some clinicians say that TPOXX should still be put through clinical trials before it is widely used for monkeypox, especially since there are no data on the drug’s use to date. man.

  • SIGA has partnered with some human trials in Africa, but those results have not been published.
  • Currently, some patients treated with TPOXX are seeing improvement, but Glesby said it’s too early to draw drastic conclusions because the natural course of the infection is still murky.
  • A placebo-controlled clinical trial would answer that question, Glesby said, adding that it’s important that people with severe cases also have immediate access to treatment.
  • The only TPOXX clinical trial in the United States evaluating it for the treatment of orthopox viruses is limited to military personnel.

The bottom line: The way monkeypox proliferates forces a rethink of the risks and benefits, especially for populations most at risk.

The FDA’s apparent reasoning, Wilkinson said, is that “the risk of giving gay and trans people a drug that has already been deemed completely safe by the FDA outweighs the risk of delaying days or even weeks, access to this antiviral”.

Editor’s note: The story has been updated to clarify that Wilkinson remark about the risks and benefits referred to the FDA’s apparent reasoning.

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