FDA Advisory Panel Rejects another NDA for a New Antibiotic
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A Food and Drug Administration (FDA) advisory panel Thursday rejected a proposed antibiotic by Arpida Ltd. (ARPN.EB) to treat serious skin infections, a Food and Drug Administration spokeswoman said. The rejection was expected because results from Phase III clinical trials showed that patients taking iclaprim (a trimethoprim-like antibiotic) had lower cure rates than Pfizer's Zyvox (linezolid) which was used as a comparator antibiotic in the studies.
The panel voted 17 to 2 against a question that asked whether the data presented demonstrated the safety and effectiveness of iclaprim for the treatment of skin infections. Although FDA isn’t required to follow the advice offered by its advisory panels, the agency typical follows the panels’ recommendations. This means that it is unlikely that FDA will approve iclaprim to treat complicated skin and soft structure infections (cSSIs).
This is bad news for Arpida Ltd, a small, Swiss biopharmaceutical company and Americans with cSSIs infections that are caused by multiple drug resistant bacteria.
Until next time…
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