SIGA will seek FDA approval of monkeypox treatment once data is available

pharmafile | August 8, 2022 | News story | Sales and Marketing  

The CEO of SIGA Technologies has announced that they are planning to ask the FDA for approval and authorisation for their drug TPOXX, as a monkeypox treatment, as soon as new efficacy data becomes available.

The US has already declared the monkeypox outbreak as a public-health emergency, allowing the FDA to issue emergency use authorisations for monkeypox therapeutics. However, on a media call, FDA Commissioner Dr Robert Califf said that TPOXX still needed to be studied closely.

“We think it’s going to be effective in monkeypox, but we have no proof of that yet,” Califf said.

SIGA’s CSO, Dennis Hruby, has expressed confidence that the drug is effective as a monkeypox treatment. “I have no doubt it will work,” Hruby said.

There are currently over 7,000 confirmed monkeypox cases in the US, and nearly 27,000 worldwide. The surge in cases that had previously been endemic only in parts of Africa could drastically expand demand for SIGA’s drug.

In 2018, the FDA approved TPOXX as a smallpox treatment in 2018, under a rule that allows for the approval of drugs based on animal data, when human trials are neither ethical nor feasible. Although the company has run safety and pharmacokinetic studies of TPOXX in humans, it tested the drug’s efficacy only in monkeys, who were infected with monkeypox, and then treated with TPOXX.

European Union and UK regulators have both approved the drug to treat monkeypox, based on the same monkey data.

SIGA’s CEO, Phil Gomez, said in a statement to Barron’s, “It’ll depend on the number of monkeypox patients, but as soon as we have any data from those trials, whether interim analysis, final data, certainly we will submit that to FDA and make sure we try and expedite the approval, either through an EUA or formal approval.”

Lina Adams

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