Industry Trend Analysis - Ilumya To Advance Sun's Non-Generic Ambitions - APR 2018
BMI View: Although the BLA is owned by Merck & Co, the FDA approval for Ilumya represents a significant advance for Sun Pharmaceutical Industries, enhancing its position both as a dermatology provider and as an innovative medicines company. Ilumya will face immediate competition in the US from Johnson & Johnson's Tremfya, the first IL-23 product to gain FDA approval, alongside Stelara. In addition, AbbVie is developing its own IL-23 drug, risankizumab. A successful marketing strategy will be crucial for Ilumya.
On March 20 2018, the FDA granted final approval for Merck & Co's BLA for Ilumya (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Ilumya selectively binds to the p19 subunit of interleukin-23 (IL-23) and inhibits its interaction with the IL-23 receptor leading to inhibition of the release of pro-inflammatory cytokines and chemokines. The drug is administered at a dose of 100mg by subcutaneous injection every 12 weeks, after the completion of initial doses at weeks zero and four. The FDA's approval letter to Merck notes that Ilumya is approved to be manufactured, filled, labelled and packaged at MSD Ireland, in Carlow, Ireland in a 100mg/1mL single-dose prefilled syringe.
The FDA approval of Ilumya was supported by data from the pivotal Phase III reSURFACE clinical development programme. In the two multicentre, randomised, double-blind, placebo-controlled trials (reSURFACE 1 and reSURFACE 2), 926 adult patients were treated with Ilumya (n=616) or placebo (n=310). Results from these studies were published in The Lancet in July 2017, with primary endpoints presented at the 25th European Academy of Dermatology and Venereology (EADV) Congress. Both Phase III studies met the primary efficacy endpoints, demonstrating significant clinical improvement with Ilumya 100mg compared to placebo when measured by at least 75% of skin clearance (PASI 75) and Physician's Global Assessment (PGA) score of 'clear' or 'minimal' at week 12 after two doses.