Advocates and lawmakers are calling for the Biden administration to remove barriers to access for a promising medication called tecovirimat, or TPOXX, as New York’s monkeypox outbreak worsens.

So far, the U.S. Food and Drug Administration has only approved the medication for the treatment of smallpox — though some early studies show TPOXX can help against monkeypox, too. The drug is an antiviral, meaning it tries to keep the virus from thriving once the germ is already harming the body. That’s in contrast to the monkeypox vaccine, which tries to stop the disease before it starts.

If a health care provider wants to try TPOXX for a monkeypox patient, they have to obtain special approval through the Centers for Disease Control and Prevention and its “Investigational New Drug” program. The program is designed to gather data on the effectiveness of TPOXX for treating monkeypox — but comes with extra steps and paperwork. This particular drug is also being supplied via the country’s Strategic National Stockpile, given that it is kept in reserve to thwart a smallpox bioterrorism attack.

State Sen. Gustavo Rivera, chairman of the Senate Health Committee, and about a dozen other state legislators sent a letter on Monday to Xavier Becerra, the secretary of the U.S. Department of Health and Human Services, urging him to consider an emergency use authorization for TPOXX, similar to the ones issued for COVID-19 vaccines before they were fully approved.

The Medical Society of the State of New York, which represents doctors, released a statement the same day calling on Becerra and President Joe Biden to declare monkeypox a public health emergency so that the FDA could evaluate TPOXX for emergency authorization.

“Tecovirimat shows great promise in the treatment of monkeypox infection, and the Emergency Investigatory New Drug restrictions have limited the ability to treat patients with this medication,” Dr. Parag Mehta, president of the Medical Society, said in the statement.

The state legislators noted in their letter that, given the strain workforce shortages have placed on health care institutions, some are finding it difficult to comply with the additional requirements.

In recent days, both New York City Mayor Eric Adams and Gov. Kathy Hochul have issued emergency declarations around monkeypox that they say will expand their powers to address the outbreak and offer funding avenues for outbreak health care.

Callen-Lorde Community Health Center, which operates clinics in the Bronx and Manhattan serving the LGBTQ population, has dedicated a six-person team to guiding patients through the complicated protocols associated with TPOXX once a clinician recommends the drug, said Dr. Asa Radix, the organization’s director of research and education.

“Most small practices cannot do this,” Radix said, adding that some patients get swabbed by other providers and then referred to Callen-Lorde for TPOXX. “We're lucky because we just had a study end, so we had some time to jump on this right away.”

Radix said Callen-Lorde has prescribed TPOXX to about 90 patients so far — about one in five of the prescriptions issued citywide. As of Tuesday, New York City health care providers had prescribed TPOXX to more than 450 monkeypox patients, according to the city health department, which is offering assistance with meeting CDC requirements. There have been more than 1,500 cases of monkeypox reported in the five boroughs so far, according to city data.

‘We should be able to move a little faster’

To prescribe TPOXX, health care providers must first swab a patient for monkeypox in person, although they don’t have to wait for the results before starting them on the medication. The patient then has to sign a form giving informed consent to receive the investigational drug, and the provider must complete a patient intake form for the CDC.

According to Radix, the process typically takes “a couple of hours” and can be more drawn out if the person is not an English speaker as the consent form is only available in English.

The health care provider then orders the medication from a central pharmacy the city has partnered with to distribute TPOXX, which is then obtained from the Strategic National Stockpile. Radix said it is typically delivered to the patient’s home the next day, but the process could take two days for those who live outside of the city.

Providers must then follow up to evaluate patients once during the 14-day course of treatment and seven to 10 days after it’s completed, given the therapy is technically part of a CDC study.

It’s a process that Radix says is much less burdensome since the CDC simplified the requirements in late July. The CDC previously required patients to keep a diary of their progress while on the drug and submit photos of their lesions, which are now optional. The CDC has also clarified that follow-up visits can be done via telemedicine and stopped requiring pharmacokinetic sampling, which involves drawing blood to evaluate how patients are reacting to the medication over time.

Most people who start it, when we follow up with them a couple days later, they say the lesions are already drying up...

Dr. Asa Radix, Callen-Lorde Community Health Center

Hospitalization and death from monkeypox are rare in this year’s outbreak. Only 10 deaths have been reported globally to the World Health Organization out of about 25,000 cases — with no fatalities coming from the U.S.

But the virus can still cause extremely painful sores and can leave scars, according to the New York City health department. Direct contact with those sores is the primary way the virus can spread.

Radix said that so far, TPOXX seems to help.

“Most people who start it, when we follow up with them a couple days later, they say the lesions are already drying up or that that pain is resolving,” he said. “People really get the most excruciating pain.”

And while he said it was valuable to gather data on TPOXX effectiveness for treating monkeypox, he added “I would hope, though, that by now they have enough information for the FDA to make this indication … We should be able to move a little faster with this.”

The U.K. and the European Union have already approved tecovirimat for monkeypox. Animal studies suggest that it is effective for treating diseases caused by orthopoxviruses, which include both monkeypox and smallpox, and reduces the chance of death. A small human study in the U.K. also reported that TPOXX can shorten the duration of symptoms relative to untreated patients.

Colorized scanning electron micrograph of monkeypox virus (green) on the surface of infected VERO E6 cells (red).

Colorized scanning electron micrograph of monkeypox virus (green) on the surface of infected VERO E6 cells (red).

arrow
Colorized scanning electron micrograph of monkeypox virus (green) on the surface of infected VERO E6 cells (red).
NIAID

In an advisory sent out to health care providers Tuesday, the city health department offered information on when to prescribe TPOXX and urged clinicians to “take the necessary steps to prescribe tecovirimat when indicated for the patients that have a positive test result (or are awaiting test results and have a clinically compatible illness).”

The advisory went on to say that providers could contact the city health department for information on getting the medication delivered to patients or their facilities.

Neither the city nor state health departments would comment on whether they support the federal government issuing an emergency authorization for tecovirimat.

But Patrick Gallahue, a city health department spokesperson, said in a statement, “Any provider can prescribe TPOXX under the current federal protocol, and the health department is a resource to help providers get started. We are providing technical assistance, treatment guidance and direct outreach to hundreds of providers across the city.”

Still, the current federal protocols are hindering access to the drug, said Dr. Erick Eiting, vice chair of operations for emergency medicine at Mount Sinai Downtown.

“There have been times when I've seen patients where I wish that there weren't these barriers in place and that I could just give them the medication,” he said.