December 8, 2023

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FDA Approves Expanded Injectable Treatment Formula for Smallpox-Monkeypox

FDA Approves Expanded Injectable Treatment Formula for Smallpox-Monkeypox


FDA Approves Expanded Injectable Treatment Formula for Smallpox-Monkeypox. 

On May 23, New York-based SIGA Technologies announced that the U.S. Food and Drug Administration (FDA) approved the TPOXX intravenous (IV) injectable formulation for the treatment of smallpox.

The intravenous formulation is an important option for those unable to swallow TPOXX oral capsules, SIGA said in a press release dated May 19, 2022.


FDA Approves Expanded Injectable Treatment Formula for Smallpox-Monkeypox


Oral formulations of TPOXX (Tecovirimat) were previously approved in the U.S., Canada and Europe.

The global approval of TPOXX includes the treatment of smallpox, monkeypox, cowpox and complications of vaccine immunization.


Recently, SIGA announced that it has initiated a clinical program to support the expansion of oral TPOXX drugs into post-exposure prophylaxis.


From a supply perspective, SIGA announced on May 12, 2022 that the U.S. Department of Defense (DoD) awarded SIGA a contract to procure up to approximately $7.5 million of oral TPOXX, of which approximately $3.6 million of oral TPOXX is scheduled for 2022 year delivery.


“We appreciate the FDA’s work in approving intravenous TPOXX, which will provide access to more patients,” SIGA CEO Dr. Dennis Hruby commented in a related media statement. “We also thank our colleagues at BARDA who have worked with us over the years to incorporate oral and intravenous TPOXX into U.S. preparedness efforts, and look forward to continuing to work with them to develop our liquid pediatric formulation.”




WHO: The course of monkeypox infection is similar to that of smallpox, but with a milder incubation period, usually 6 to 13 days

On May 23, according to @CCTV Finance, according to WHO, the symptoms of monkeypox virus infection are similar to those of smallpox, but the clinical severity is less severe.

The incubation period is usually 6 to 13 days and may be as long as 21 days.

The initial symptoms of monkeypox infection in humans include fever, headache, muscle aches, back pain, and swollen lymph nodes, which can later develop into a widespread rash on the face and body.

Most infected people recover within a few weeks, but others become seriously ill and even die.


WHO data shows that the smallpox vaccine is 85% effective against monkeypox virus.


Previously reported that on the 22nd local time, the BBC reported that Israel, Switzerland and Austria had also reported confirmed cases of monkeypox in the past two days, and the number of countries reporting confirmed cases in this round has increased to 15.


In addition, many countries, such as the United States and the United Kingdom, where cases of monkeypox have been found, have recently reported the discovery of new confirmed or suspected cases. The WHO has warned that more monkeypox cases may be detected in the future.


Data show that monkeypox is a viral zoonotic disease that occurs in monkeys in the rainforests of central and western Africa, and can also infect other animals and occasionally humans.


Infected people will develop a large rash on the face and body surface, including the inside of the mouth, palms, and soles of the feet.

Pain-triggering pimples are pearly, fluid-filled bumps, often with a red circle of surrounding skin, and the lesions eventually crust over and heal within two to three weeks.




(source:internet, reference only)

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Important Note: The information provided is for informational purposes only and should not be considered as medical advice.