FDA Greenlights Pretomanid Tablets to Treat Drug-Resistant Tuberculosis

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The US Food and Drug Administration (FDA) announced on Wednesday its approval for the usage of pretomanid tablets, which in combination with medications bedaquiline and linezolid are expected to help treat individuals diagnosed with drug-resistant tuberculosis of the lungs.

Tuberculosis, otherwise known as TB, is a highly infectious disease caused by the mycobacterium tuberculosis bacteria. The disease mainly affects the lungs and is spread by airborne respiratory droplets when an infected individual either sneezes or coughs.

Officials were able to determine the effectiveness of the new drug after reviewing data collected from a clinical trial that looked into 109 patients diagnosed with “extensively drug-resistant, treatment-intolerant or non-responsive multidrug-resistant pulmonary TB (of the lungs).” Of the group, it was concluded that 95 of the individuals who were given the new drug therapy were cured.

However, those successes didn’t come without a few setbacks. As is the case with many medications, patients reported experiencing a variety of reactions and side effects, some of which included: damaged nerves, acne, anemia, nausea, vomiting, headaches, increased live enzymes, indigestion, rash, increased pancreatic enzymes, visual impairment, low blood sugar and diarrhea.

“We’re very optimistic that this will help save a lot of lives,” Mel Spigelman, president and CEO of Global Alliance for TB Drug Development Inc. (TB Alliance), the company that developed the new drug, told the Wall Street Journal. “If we can find good new drugs, even the worst cases of TB can be treated in a reasonable manner.”

Developed by a nonprofit organization, pretomanid is just the third FDA-approved TB drug to come out in the last 40 years, according to TB Alliance. The new drug therapy is expected to be available to TB patients by the end of 2019.

In an effort to push the therapy globally, TB Alliance is working to obtain an approval from the European Medicines Agency and seeking the drug’s inclusion into the World Health Organization’s treatment guidelines for highly drug-resistant TB cases.

According to the US Centers for Disease Control and Prevention, some 10 million people worldwide were diagnosed with TB in 2017, and an estimated 1.3 million people died globally as a result of TB-related illnesses. The agency reported that 9,105 cases of TB were reported in the US that year, marking the lowest case count since records first began.

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