Sun Pharma Announces U.S. FDA Approval of ILUMYA (tildrakizumab-asmn) for the Treatment of Moderate-to-Severe Plaque Psoriasis
The US Food and Drug Administration (FDA) has approved tildrakizumab-asmn (Ilumya, Sun Pharmaceuticals) for adults with moderate-to-severe plaque psoriasis who are eligible for systemic therapy or phototherapy, the company has announced.
Tildrakizumab-asmn is a selective interleukin (IL)-23p19 inhibitor given by subcutaneous injection at a dose of 100 mg every 12 weeks, after the completion of initial doses at week 0 and week 4, the company said.
The efficacy of tildrakizumab-asmn for moderate-to-severe plaque psoriasis was demonstrated in the phase-3 reSURFACE clinical development program. The two multi center, randomized, double-blind, placebo-controlled trials known as reSURFACE 1 and reSURFACE 2 involved 926 adults with moderate-to-severe plaque psoriasis with 616 treated with tildrakizumab-asmn and 310 with placebo.
Both studies met the primary efficacy endpoints, demonstrating significant clinical improvement with tildrakizumab-asmn compared with placebo when measured by at least a 75% reduction in Psoriasis Area and Severity Index score (PASI 75) and Physician Global Assessment (PGA) score of “clear” or “minimal” at week 12 after two doses.
In the reSURFACE 1 study, 74% of patients achieved PASI 75 at week 28 after three doses of tildrakizumab-asmn, and 84% of patients who continued on the drug maintained PASI 75 at week 64 compared with 22% of patients who were rerandomized to placebo.
In addition, according to the company, 69% of the patients receiving tildrakizumab-asmn who had a PGA score of “clear” or “minimal” at week 28 maintained this response at 64 weeks compared with 14% of patients who were rerandomized to placebo.
Results from the reSURFACE 1 and 2 studies were published last year in The Lancet, as reported by Medscape Medical News.
The most common (≥ 1%) adverse reactions associated with tildrakizumab-asmn include upper respiratory infections, injection site reactions, and diarrhea. Adverse reactions that occurred at rates less than 1% but greater than 0.1% in acti ve treatment arms and at a higher rate than in the placebo groups included dizziness and pain in extremity.In the clinical trials, cases of angioedema and urticaria were reported with tildrakizumab-asmn. I n the case of serious hypersensitivity reaction, the drug should be stopped immediately and appropriate therapy initiated, the company said.Tildrakizumab-asmn may increase the risk for infection, and treatment should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. The risks and benefits of treatment should be considered in patients with chronic infection or a history of recurrent infection. Patients should be evaluated for tuberculosis infection prior to starting treatment and throughout treatment.
Full prescribing information is available online.