Sun Pharmaceutical announces the U.S. Food and Drug Administration (FDA) acceptance of the Biologics License Application (BLA) for tildrakizumab.
The FDA filing acceptance follows acceptance of the regulatory filing of tildrakizumab by the European Medicines Agency (EMA) in March 2017. Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis. The BLA filing for tildrakizumab was submitted by Merck & Co.
"At Sun Dermatology, we are committed to making a difference in the lives of patients and healthcare providers,” Abhay Gandhi, CEO - North America Business, Sun Pharma said. “The acceptance of the regulatory filing by the U.S. FDA marks a significant milestone as we seek to advance for tildrakizumab as a potential new treatment option for people who continue to struggle everyday with the chronic nature of psoriasis."
The BLA filing for tildrakizumab with the U.S. FDA is based on two pivotal Phase III trials (reSURFACE 1 and 2) which included over 1,800 patients across more than 200 clinical trial sites, including some patients who have been treated with tildrakizumab for up to three and a half years.
Psoriasis is a chronic immune disease that appears on the skin. It affects an estimated 7.5 million people in the U.S. and approximately 125 million people worldwide. It is a non-contagious disorder that speeds the growth cycle of skin cells and results in thick scaly areas of skin. The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed.
Tildrakizumab is an investigational humanized, anti-IL-23p19 monoclonal antibody designed to selectively block the cytokine IL-23. With this precise targeting, tildrakizumab has the potential to help control the pathogenic cells responsible for the inflammatory process of psoriasis with limited impact on the rest of the immune system. Phase-3 tildrakizumab data provide further evidence for the role of the IL-23 pathway in helping to control the inflammatory process of psoriasis.
Tildrakizumab Phase-3 studies (reSURFACE 1 and 2) are randomized, placebo-controlled, multicenter, three-part studies designed to demonstrate efficacy of tildrakizumab in moderate-to-severe plaque psoriasis compared to placebo and comparative drug and to assess safety and tolerability. Part one of the studies randomized patients into three or four treatment arms, including tildrakizumab 200mg, tildrakizumab 100mg, placebo and etanercept (reSURFACE 2 only). After Week 12 patients on placebo and etanercept were then re-randomized into tildrakizumab 200mg and 100mg treatment arms to proceed into part two of the studies. Finally, in part three of the studies, responders (PASI ≥75) and partial responders (PASI ≥50 and PASI <75) were re-randomized after Week 28 continue the same treatment, a different dose of tildrakizumab or placebo.