The U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for Sun Pharmaceutical’s lead investigational drug tildrakizumab to treat moderate-to-severe plaque psoriasis.
Merck, which since 2014 has had a drug development and commercial agreement with India’s Sun, filed the BLA following acceptance by the European Medicines Agency (EMA) of the regulatory filing of tildrakizumab by Almirall.
“At Sun Dermatology, we are committed to making a difference in the lives of patients and healthcare providers,” Abhay Gandhi, CEO of Sun Pharma’s North America Business, said in a press release, noting that the FDA’s acceptance of the BLA “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.”
Tildrakizumab, also known as MK-3222, is an investigational antibody that selectively targets a pro-inflammatory protein called IL-23p19. Its inhibitory activity has the potential to regulate the inflammatory response involved in psoriasis, with limited effects on the remaining immune system responses.
The BLA filing and acceptance for tildrakizumab followed positive results of two pivotal Phase 3 trials (NCT01722331 and NCT01729754), the reSURFACE 1 and 2 studies. Including about 1,800 patients in more than 200 clinical sites, these studies tested the efficacy and safety of tildrakizumab for treatment of patients with moderate-to-severe chronic plaque psoriasis in comparison with placebo or comparative drug, such as Enbrel (etanercept), for up to three and a half years.
Preliminary reSURFACE data have shown that tildrakizumab was able to induce a 75 percent improvement in Psoriasis Area and Severity Index (PASI 75) in more than 60 percent of patients, compared to only 6 percent of patients on placebo. In addition, this positive effect continued for up to 64 weeks after treatment.
This new therapy induced meaningful clinical benefits to those patients who did not respond to Enbrel treatment, supporting its therapeutic potential. These clinical results were the subject of three poster presentations at the 2017 American Academy of Dermatology‘s annual meeting, held March 3-7 in Orlando, Florida.
The results of future reSURFACE trials on the long-term efficacy and safety of tildrakizumab will be presented in upcoming scientific meetings.