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June 4, 2021Tembexa Approved to Treat Smallpox
June 4, 2021 – The U.S. FDA has approved Tembexa® (brincidofovir), manufactured by Chimerix, to treat smallpox. Although naturally occurring smallpox has been eradicated since 1980, samples of the smallpox virus still exist in laboratory settings. It is possible smallpox could infect humans through accidental release or deliberate use as a biological weapon.
Smallpox is a potentially fatal disease that causes fever, fatigue, aches, and a rash of small, pink bumps that become pus-filled sores. Complications include encephalitis (brain inflammation), corneal ulcers (open sores on the surface of the eye), and loss of vision. The virus can spread easily from person to person, and historically had a fatality rate of approximately 30%.
In animal trials, Tembexa improved smallpox survival rates compared to placebo. It was not tested in humans for efficacy against smallpox as this would have required infecting human trial subjects with the virus. The drug’s safety in humans was extrapolated from clinical trials evaluating it for a non-smallpox indication. However, Tembexa is currently only approved to treat smallpox.
Recommended dosing is based on the patient’s weight. Tembexa is taken by mouth in either oral solution or tablet form once a week for two weeks. A black box warning cautions that there is an increased risk of mortality when Tembexa is used for a longer period, which was identified during a clinical trial that evaluated it for a non-smallpox indication.