FDA rejects Arpida's iclaprim for cSSSI

The US Food and Drug Administration says it needs more evidence of efficacy before it can approve Swiss firm Arpida's intravenous iclaprim  for the treatment of complicated skin and skin structure infections.

Commenting on the complete response letter, company chief executive  Jurgen Raths said: "after the negative recommendation of the Advisory  Committee of last November, the FDA opinion comes as no surprise. We  now aim to develop a viable roadmap to approval in close consultation  with the FDA. The drastic cost saving measures that we've recently  implemented should buy us sufficient time to consider and develop  strategic options for progressing iclaprim's development."

Last year, Arpida announced plans to reduce its workforce by up to 60  employees, while consulting external experts to determine the future  development of iclaprim (Marketletter December 8, 2008).