FDA Approves Novel Biologic for Plaque Psoriasis

Today, the FDA approved tildrakizumab-asmn (Ilumya) for the treatment of moderate-to-severe plaque psoriasis among patients who are candidates for systemic therapy or photo therapy, according to a press release from Sun Pharmaceuticals.

Tildrakizumab-asmn selectively binds to the p19 subunit of the cytokine IL-23 and blocks interaction with its receptor. This action prevents the release of inflammatory cytokines and chemokines, according to the release.

Tildrakizumab-asmn is indicated at a dose of 100-mg administered as a subcutaneous injection every 12 weeks, following initial doses at weeks 0 and 4, Sun Pharma reported.

The approval of tildrakizumab-asmn was based on positive findings in the phase 3 reSURFACE clinical development program. In reSURFACE 1 and reSURFACE 2, 926 adults with moderate-to-severe plaque psoriasis were treated with tildrakizumab-asmn or placebo.

Sun Pharma reported that both trials met their primary efficacy endpoints of significant clinical improvement with tildrakizumab-asmn 100-mg compared with placebo, as measured by achieving Psoriasis Area Sensitivity Index 75 (PASI 75) and a Physician’s Global Assessment (PGA) score of clear or minimal at week 12.

The researchers found that 74% of patients in reSURFACE 1 achieved PASI 75 at week 28 after 3 doses. Approximately 84% of patients who continued therapy maintained this level of skin clearance at 64 weeks compared with 22% of patients who were re-randomized to receive placebo, according to the release.

Additionally, 69% of patients who achieved a PGA score of clear or minimal at 28 weeks maintained this response at 64 weeks compared with 14% of patients who were re-randomized to receive placebo.

Sun Pharma noted that some patients treated with tildrakizumab-asmn experienced angioedema and urticaria. The drug may also increase the risk of infection; thus, the risks and benefits of treatment should be considered in patients with a chronic infection or a history of recurrent infections, according to the release.

The most common adverse events include upper respiratory infections, injection site reactions, and diarrhea.

“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,” said Abhay Gandhi, president and chief executive officer, North America, Sun Pharma. “We are committed to working with all relevant stakeholders to make Ilumya available to appropriate people with plaque psoriasis.”