Sun Pharma Announces US FDA Filing Acceptance of Biologics License Application (BLA) For Tildrakizumab
Tildrakizumab is being evaluated for treatment of moderate-to-severe plaque psoriasis
May 24, 2017, 08:03 ET
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MUMBAI, India and PRINCETON, N.J. , May 24, 2017 /PRNewswire/ — Sun Pharmaceutical Industries Ltd (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries or associate companies) 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., Inc., Kenilworth, NJ , USA.
According to Abhay Gandhi , CEO – North America Business, Sun Pharma, “At Sun Dermatology, we are committed to making a difference in the lives of patients and healthcare providers. 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. Data from these trials were most recently presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting in March and previously presented at the 25 th European Academy of Dermatology and Venereology Congress. Future presentations and publications of the reSURFACE Phase-3 pivotal trials will include more scientific insights on the data to week 52 and beyond. The clinical trials are designed to evaluate safety and efficacy for up to five years, and to date, some clinical trial participants have been treated with tildrakizumab for up to three and half years.
About Tildrakizumab Phase-3 reSURFACE Trial Design
The co-primary efficacy endpoint of the two placebo controlled studies were the proportion of patients with Psoriasis Area Sensitivity Index 75 (PASI 75) response at week 12 compared to placebo and the proportion of participants with a Physician’s Global Assessment (PGA) score of clear or minimal with at least a 2 grade reduction from baseline at week 12 compared to placebo. The reSURFACE 2 also included a key secondary endpoint comparing tildrakizumab and etanercept on PASI 75 and PGA. Other co-secondary endpoint of both placebo controlled studies included PASI 90 and PASI 100 responses at week 12 and PASI 75, 90 and 100 and PGA responses from baseline at Week 28. PGA measures lesion thickness, erythema and scaling across all of a patient’s psoriasis lesions in order to determine the disease activity on a six-point scale from “clear” to “severe.” A PASI score is a measure of psoriatic plaque redness, scaling and thickness and extent of the involvement in each region of the body. Treatment efficacy is often measured by reduction of PASI from baseline (i.e. 75 percent reduction is known PASI 75), a 90 percent reduction is known as PASI 90 and PASI 100 is total clearance of skin disease.
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