FDA Advisory Committee Greenlights Three-Drug Cocktail for TB

A panel of experts urged the FDA to approve a three-drug cocktail that backers say has produced miraculous results in patients with a particularly nasty form of tuberculosis.

By a vote of 14—4, the Antimicrobial Advisory Committee recommended the Global Alliance TB Drug Development’s application to add pretomanid tablets in combination with bedaquline and linezolid for extensively drug resistant and treatment-intolerant or non-responsive multidrug-resistant tuberculosis.

The approval came after lengthy discussion and despite concerns from some critics that the Alliance’s main trial design wasn’t robust enough to overcome worries about some of the liver and fertility side effects connected to pretomanid.