FDA Approves New Drug to Help Fight Treatment-Resistant Tuberculosis

The U.S. Food and Drug Administration has approved a new drug to help fight deadly types of tuberculosis that are highly resistant to treatment.

The FDA announced Wednesday that the newly-approved Pretomanid Tablets work in combination with bedaquiline, which was approved on its own in 2012, and linezolid to treat “a limited and specific population of adult patients with extensively drug resistant, treatment-intolerant or nonresponsive multidrug resistant pulmonary TB.”

“The threat of antimicrobial-resistant infections is a key challenge we face as a public health agency,” said FDA Principal Deputy Commissioner Amy Abernethy said in a statement.

Abernathy called treatment-resistant TB a “public health threat,” and said the new treatments were important in keeping up with the needs of patients worldwide.

Because of this, the FDA has been focused on coming up with new treatments that’ll give patients – which numbered more than 490,000 in 2016, according to the World Health Organization – more options to fight infections.

A study that evaluated 107 patients, each with some form of treatment-resistant TB, found that after six months, 89 percent were considered “successes.”

A spokeswoman for Mylan NV, which received a license in April to manufacture and sell the new treatment, told Reuters that if approved, the company hopes to have the oral, six-month treatment regimen available by the end of the year.

1.3 million people died of tuberculosis in 2017, according to the Centers for Disease Control, and the New York Times reports it’s the world’s leading infectious cause of death.

The Times also reports there are about 30,000 cases in over 100 countries of a TB strain called XDR, the deadliest of strains, as it is resistant to all four types of antibiotics typically used to fight TB.

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