FDA Advisory Panel Split On Recommending New TB Treatment For Approval
Devex: Will a new TB treatment be available soon?
“Experts advising the U.S. Food and Drug Administration on marketed and investigational drugs for infectious diseases and disorders were divided on whether the regulatory agency should approve a new drug as part of a proposed combination therapy for highly resistant tuberculosis. The majority of the independent experts — 14 out of 18 — advising the regulatory agency voted favorably last month. But the remaining four found insufficient evidence on efficacy and safety of the TB Alliance’s oral anti-TB drug pretomanid when used in combination with bedaquiline and linezolid, or BPaL. … If the U.S. FDA approves the drug, the TB Alliance and its pharmaceutical partner, Mylan, will have permission to market the drug in the U.S…” (Ravelo, 7/5).