FDA bars Basilea antibiotic from U.S. market, demands new PhIII data

June 25, 2014 2:56 PM

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Close to a year ago Switzerland's Basilea raised a red flag about its U.S. strategy for its antibiotic ceftobiprole, noting that the FDA's new standard requiring two late-stage studies for a program like this could present a major hurdle. Today company execs confirmed that the regulatory path into the U.S. is closed for now, noting the FDA's insistence on more Phase III data and adding that it has no plans to launch a new study without a U.S. partner in hand.

"The FDA confirmed that the current ceftobiprole studies should be complemented with prospective data in community and hospital-acquired pneumonia in accordance with its new guidelines," the company said in an announcement. "Basilea does not currently intend to initiate new Phase III trials for ceft...

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