The US Food and Drug Administration (FDA) approved pretomanid today, a “major” breakthrough treatment for the most drug-resistant tuberculosis (TB) when used in combination with bedaquiline and linezolid.

It is only the third TB drug approved by the FDA in more than 40 years, according to a news release from RTI International, one of the collaborators in the drug’s development.

The pretomanid combination treats extensively drug-resistant tuberculosis ( XDR-TB), a type of multidrug-resistant tuberculosis (MDR-TB) of the lungs that is resistant to the two strongest TB drugs, isoniazid and rifampin, as well as to any fluoroquinolone and at least one of three injectable second-line drugs (amikacin, kanamycin, or capreomycin).

The FDA said in a news release that the safety and effectiveness of the pretomanid combination, taken orally, was primarily demonstrated in a study of 109 patients with extensively drug-resistant, treatment‑intolerant, or nonresponsive MDR-TB. Of the 107 patients who were evaluated 6 months after the end of therapy, 95 (89%) had successful treatment, far exceeding success rates of available treatments.

Amita Gupta, MD, professor of medicine and deputy director of the Johns Hopkins University Center for Clinical Global Health Education in Baltimore, Maryland, told Medscape Medical News there was much anticipation of this announcement.

“This is a very exciting development,” she said. “It will be a game changer for these highly resistant patients.”

There are very few treatments for people with XDR-TB, she noted, cure rates are very low (a trial in South Africa showed 2%-22% cure rates), treatment duration is typically 2 years, mortality rates are as high as 80%, and treatments have had severe toxicities.

The New Drug Application (NDA) for pretomanid said previous treatments have typically involved taking at least five drugs, some intramuscular, some intravenous, with no defined regimen and with side effects that can include deafness, renal failure, and psychosis.

The pretomanid regimen, on the other hand, is all-oral, well tolerated, has a treatment duration of 6 months, and cure rate of 89%, she noted.

The most common adverse reactions observed from the pretomanid combination “included damage to the nerves (peripheral neuropathy), acne, anemia, nausea, vomiting, headache, increased liver enzymes (transaminases and gamma-glutamyltransferase), indigestion (dyspepsia), rash, increased pancreatic enzymes (hyperamylasemia), visual impairment, low blood sugar (hypoglycemia), and diarrhea,” the FDA said.

The FDA also warned that the combination should not be used in patients with hypersensitivity to bedaquiline or linezolid.

Now the question, Gupta said, is whether the population that needs the drug combination will have affordable …read more

Source:: Daily Times

      

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FDA OKs ‘Game Changer’ Pretomanid for Highly Resistant TB

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