On 20/Aug/2019 / In Articles
The Food and Drug Administration, FDA, has approved a medication for treatment of drug-resistant tuberculosis infection. The drug, an antibiotic called Pretomanid is targeted at the most dangerous types of tuberculosis infections known as Extensively Drug-Resistant tuberculosis, XDR-TB, and mullti-drug-resistant TB, MDR-TB, which is resistant to at least four of the main TB drugs, and treatment often fails. Only around 34 percent of infected patients with drug resistant TB typically survive, according to the World Health Organisation.
Pretomanid has been developed and clinically evaluated by TB Alliance, a not-for-profit product development partnership dedicated to the discovery and development of new, faster-acting and affordable medicines for TB. Becoming ill with this type of TB “can be a death sentence — until now,” says William Bishai, a tuberculosis researcher at the Johns Hopkins University School of Medicine. Current TB treatment requires patients to take as many as eight antibiotics orally, and sometimes by injection, for 18 months or more. The new antibiotic is paired with two other previously approved drugs, Bedaquiline and Linezolid, in a six-month course of pills. Ninety-five of 107 patients who had the highly resistant disease and took the drug regimen recovered, according to the TB Alliance.
Tuberculosis affected about 10 million people in 2017. Around 558,000 cases were multidrug-resistant, unresponsive to the two most powerful TB drugs. Of those cases, about 8.5 percent, or roughly 47,000, were XDR-TB, according to WHO. Although Pretomanid has been tested only in patients with highly resistant TB, more research is needed to determine whether the drug could be useful for the vast majority of patients who have TB that’s more receptive to treatment. The standard regimen of multiple drugs taken for six months could be shortened by including the new antibiotic. This treatment regimen for XDR-TB could help stem the growing problem of hard-to-treat TB infections.
In clinical trials for extensively drug-resistant (XDR) TB, nearly 90 percent of patients receiving the medication recovered after six months of treatment—almost three times the success rate of current treatment options, which involve taking antibiotic cocktails for up to two years. Pretomanid was developed by the TB Alliance. “One definite advantage of a not-for-profit is you don’t have to look at things like returning your profits into shareholders,” Mel Spigelman, President and CEO of TB Alliance. TB Alliance has licensed the therapy and filed for approval of pretomanid as part of a combo regimen for TB with European regulatory authorities. Nigeria is one of the countries included among the 30 high burden countries for TB, TB/HIV and drug-resistant -TB. According to the WHO, the proportion of patients with MDR-TB is 4.3 percent among new cases and 25 percent among previously-treated cases in Nigeria.
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