Novartis AG has been asked to give a U.S. regulator more clinical data on its prospective gouty arthritis treatment and potential blockbuster, ACZ885, so that it can evaluate the benefit-risk profile in a subset of patients. The Swiss drugmaker said on Monday it would work with the U.S. Food and Drug Administration on the next steps and that it was committed to studying ACZ885, or Ilaris, in inflammatory diseases. Earlier this year, the FDA voted in favour of the overall efficacy, but said additional retreatment data was needed to access the overall safety profile of the drug.
