It’s a tough road ahead for Sun Pharma’s newly approved Ilumya, according to a new report from GlobalData, a leading data and analytics company.
In March 2018 the US Food and Drug Administration (FDA) approved Sun Pharma’s Ilumya for the treatment of adults with moderate-to-severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy. Ilumya is the second interleukin-23 (IL-23) inhibitor to gain FDA approval within the past year, following the approval of J&J’s Tremfya in July 2017.
These recent approvals follow an influx of IL-17 inhibitors into the US PsO market between January 2015 and February 2017, including Novartis’ Cosentyx , EIi Lilly’s Taltz, and Valeant’s Siliq.
GlobalData anticipates that Sun Pharma will face an uphill battle marketing Ilumya in the US. J&J has an eight-month head start marketing Tremfya in the US, while IL-17 inhibitor Cosentyx reached blockbuster status in 2016, and Taltz and Siliq are not far behind. With nine biologics now approved for the treatment of PsO in the US – not to mention biosimilars – IL-23 inhibitors, especially Ilumya, face significant challenges to establish themselves in an already overcrowded market.
The FDA approval of Ilumya was based on the results of the Phase III reSURFACE clinical development program, including two multicenter, double-blind, placebo-controlled trials (reSURFACE1 and reSURFACE2). In the reSURFACE1/reSURFACE2 studies, 64 percent/61 percent and 58 percent/55 percent of patients who received Ilumya (100mg) achieved a PASI75 score and PGA 0/1 at Week 12, respectively, compared with 6 percent/6 percent and 7 percent/4 percent of patients receiving placebo.
In terms of safety, the drug comes with a warning for hypersensitivity, infections, and tuberculosis. The most common adverse events associated with use of Ilumya are upper respiratory tract infections, injection site reactions, and diarrhea. However, Tremfya and all three marketed IL-17 inhibitors are associated with similar warnings, and therefore GlobalData does not expect Ilumya’s safety profile to impact its performance in the US market.