FDA grants RHB-204 'orphan drug eligibility' to treat non-tuberculosis mycobacteria (NTM) infections

Almost half of non-TB mycobacteria (NTM) is associated with opportunity-related infections in humans and animals, and some cause explosive infections.
non-TB mycobacteria infections are obtained through exposure to the environment, such as exposure to water, suspended particulates, soil and dust.
non-TB mycobacteria can cause suspected tuberculosis, lymph node infections, bone infections, abscesses, and skin and soft tissue infections in the lungs, which can be confined or scattered throughout the body.
, a biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted RHB-204 "orphan drug eligibility" to treat non-tuberculosis mycobacteria (NTM) infections.
, vice president of Red Hill, said: "NTM infections are resistant to most antibiotics and are extremely difficult to treat.
there is no FDA-approved first-line therapy, there is an urgent need for new treatments for this potentially deadly infectious disease."
's ongoing multi-center, randomized, double-blind, placebo-controlled, parallel group III study recruited 125 patients in more than 40 locations in the United States who were randomly assigned RHB-204 or a placebo in a 3:2 ratio to assess the safety and effectiveness of RHB-204.
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