Case of PML reported in efalizumab-treated patient

The FDA has set a date of July 07, 2024, for Zorvye 0.15% for adults and children six and up with the chronic skin disease atopic dermatitis.

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.

The decision by Scripius (previously Select Health Prescriptions) was made based on the cost of Dupixent, as well as because of an increased demand to use Dupixent for mild atopic dermatitis when the primary patient population is those with moderate to severe disease.