The FDA is requesting additional efficacy data to support an approval for patients with chronic spontaneous urticaria; results of an ongoing study are expected late next year.
The dosage of Zoryve for children 6 to 11 is the same as for those over the age of 12. The list price is same for both pediatrics and adults — $825 per tube.
Galderma officials said they have already identified changes to its manufacturing process for relabotulinumtoxinA, which is being reviewed as a treatment for frown lines and crows feet.
At issue are findings from the agency’s inspection of a third-party manufacturing company. The FDA indicated there were no concerns about the safety or labeling of lebrikizumab.