Today, Sun Pharma announced that Ilumya has been approved by the FDA for the treatment of moderate-to-severe plaque psoriasis in adults who are eligible for systemic therapy or phototherapy.
“With the approval of Ilumya and our long-standing commitment in dermatology, we are focused on making a difference for people living with moderate-to-severe plaque psoriasis,” Abhay Gandhi, president and CEO of the North American division of Sun Pharma, said in a press release. “We are committed to working with all relevant stakeholders to make Ilumya available to appropriate people with plaque psoriasis.”
The FDA approval of Ilumya (tildrakizumab-asmn, Sun Pharma) is based on data from two phase 3 multicenter, randomized, double-blind, placebo-controlled trials (reSURFACE 1 and reSURFACE 2), according to the release. The studies evaluated the efficacy of tildrakizumab-asmn in 926 adults with moderate-to-severe plaque psoriasis compared with placebo.
At week 28, most participants (74%) achieved 75% skin clearance with three doses of 100 mg of tildrakizumab-asmn, according to the release. At week 64, 75% skin clearance was maintained by 84% of patients who continued taking tildrakizumab-asmn compared with 22% of patients re-randomized to placebo, according to the release.
A Physician’s Global Assessment score of “clear” or “minimal” was maintained at week 64 in 69% of patients receiving tildrakizumab-asmn who achieved the score at week 28, compared with 14% of those who were re-randomized to receive placebo, according to the release.
In patients who showed prior severe hypersensitivity reaction to tildrakizumab or any of the excipients, tildrakizumab-asmn was contraindicated, according to the release.
“Now that Ilumya is approved, we are currently working closely with Merck and the FDA to complete the post-approval commitments,” Sun Pharma told Healio Internal Medicine. “Once this step is complete, we will have a better understanding of when the product will be available for patients.”