FDA Approves Tildrakizumab for Certain Plaque Psoriasis Patients

The US Food and Drug Administration (FDA) has approved tildrakizumab-asmn (ILUMYA) for the treatment of adults with moderate to severe plaque psoriasis who are eligible for systemic therapy or phototherapy.

The therapy, from Sun Pharma, was approved on the evidence of a pivotal phase 3 clinical development program (reSURFACE) which tested the efficacy of the inhibitor versus placebo in 926 adult patients.

The reSURFACE program was split into 2 multicenter, randomized, double-blind trials, with primary endpoints showing significant clinical improvement measured by at 75% skin clearance and Physician’s Global Assessment (PGA) score of “clear” or “minimal” after 2 doses of 100 mg tildrakizumab at week 12. Skin clearance was measured with the Psoriasis Area Sensitivity Index (PASI).

In the first study, 309 adult patients with plaque psoriasis were administered 100 mg tildrakizumab, and 154 were administered placebo. At the end of 12 weeks, 179 (58%) of treatment patients reported PGA “clear” or “minimal” scores, compared to 11 (7%) in the placebo patient group.

Another 197 (64%) treatment patients reported PASI clearance of at least 75%. From there, 107 (35%) reported 90% clearance, and 43 (14%) reached 100% clearance. Only 9 (6%) of placebo patients achieved at 75% clearance, 4 (3%) reached 90% clearance, and 2 (1%) reached 100%.

In an extension to the study, 229 (74%) of treatment patients eventually reached 75% skin clearance at week 28 after 3 doses, and 84% of the patients to achieve PASI 75 at week 12 with 100 mg tildrakizumab maintained the clearance through week 64. Another 69% of the patients to reach endpoint PGA scores at week 28 maintained the response at week 64, while just 14% of patients who were re-randomized to placebo.

The results of the study were published in July last year, and its primary endpoints were presented at the 25^th European Academy of Dermatology and Venereology (EADV) Congress. Adhay Gandhi, president and chief executive officer, North America, Sun Pharma, said the company is committed to working with all relevant stakeholders to make ILUMYA available to appropriate patients with plaque psoriasis.

“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,” Ghandi said.

Tildrakizumab-asmn is a selective interleukin (IL)-23 binder that inhibits the protein’s interaction with the receptor, blocking pro-inflammatory cytokine and chemokine release. As a 100 mg subcutaneous injection therapy, ILUMYA is administered every 12 weeks, with initial doses at baseline and week 4. It is contraindicated in patients with a history of hypersensitivity reaction to tildrakizumabo or to any of its other excipients.

The therapy joins a market of biologic competitors including adalimumab (Humira) and ustekinumab (Stelara).