Theravance’s Persistence On Telavancin Rewarded With Positive Cmte. Vote
FDA’s Anti-Infective Drugs Advisory Committee endorsed Vibativ for limited use in nosocomial pneumonia. The committee was convened at the recommendation of Office of New Drugs Director John Jenkins, who denied the company’s appeal of a second “complete response” letter but urged the NDA be re-evaluated.
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More companies are turning to CDER’s formal appeals process when presented with a review division’s regulatory decision or advice. Even though few appeals are granted in full, many sponsors get valuable clarity on a path forward; some appeals, like that for Amarin’s Vascepa SPA, are turned away at the door.
Company has secured a new third-party manufacturer for the antibiotic and says it will relaunch the drug in the third quarter. FDA approval for telavancin’s use in hospital-acquired pneumonia comes four-and-a-half years after the original NDA submission for the supplemental claim.
Theravance could soon have its first substantial revenue generator on the market, the COPD therapy Breo Ellipta partnered with GlaxoSmithKline. The launch of Breo is just one of several catalysts expected to unfold for the biotech in 2013.