Sun Pharma announces Australian TGA approval of ILUMYA™ (tildrakizumab)
Deepthi | Myequity news | Date : 21-09-2018 12:30:00 IST
Sun Pharma has received the Australian Therapeutic Goods Administration (TGA) approval for its speciality product, ILUMYA™ (tildrakizumab) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
ILUMYA™ selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor leading to inhibition of the release of proinflammatory cytokines and chemokines. ILUMYA™ is administered at a dose of 100 mg by subcutaneous injection every 12 weeks after the completion of initial doses at weeks 0 and 4. ILUMYA™ is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients in ILUMYATM, and in patients with clinically important active infections, e.g. active tuberculosis.
“We are pleased to have received this approval and look forward to bringing ILUMYATM to dermatologists and patients in Australia,” said Hellen De Kloet, Business Head, Western Europe & Australia, Sun Pharma. “We are launching a patient support program to assist patients prescribed with ILUMYA™. The program is designed to supplement the support offered by doctors in their practice or in hospital departments.” she added.
The ILUMYA™ patient support program offers self-injection training by a registered nurse, dose reminders, injection consumables and a patient support help line.
ILUMYA™ is one of the key specialty products of Sun Pharma and it was approved by US FDA in March 2018 while the European Commission approved it in September 2018.
In Australia, the number of severe chronic plaque psoriasis patients receiving treatment through the Pharmaceutical Benefit Scheme (PBS) with biologics, increased by more than 60% between 2014 and 2016. However, the number treated was less than 30% of the severely affected population. The total PBS expenditure on biologicals for chronic plaque psoriasis (at published prices) was A$121 million in 20161.
The TGA approval of ILUMYA™ for the treatment of adults with moderate-to-severe plaque psoriasis was supported by data from the pivotal Phase-3 reSURFACE clinical development program. In the two multicentre, randomized, double-blind, placebo-controlled trials (reSURFACE 1 and reSURFACE 2), 1862 adult patients were enrolled and treated with ILUMYA™ (N=1238), etanercept (N=313) 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-3 studies met the primary efficacy endpoints, demonstrating significant clinical improvement with ILUMYA™ 100 mg compared to placebo or etanercept when measured by at least 75 percent reduction in baseline psoriasis severity (Psoriasis Area Sensitivity Index or PASI 75) and Physician’s Global Assessment (PGA) score of “clear” or “minimal” at week 12 after two doses. About Sun Pharma, Merck & Co., Inc., Kenilworth, NJ, USA, Agreement:
Sun Pharmaceutical Industries Ltd.’s wholly owned subsidiary licensed worldwide rights to Tildrakizumab from a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, in 2014. Funded by a Sun Pharma subsidiary, Merck & Co., Inc., Kenilworth, NJ, USA is responsible for the completion of Phase-3 trials in patients with moderate-to-severe plaque psoriasis and submission of a Biologics License Application to the United States Food and Drug
Administration (FDA), as well as manufacturing finished goods to support Sun Pharma’s initial product launch. Sun Pharma will be responsible for all post-approval regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Sun Pharma will also be responsible for all regulatory, pharmacovigilance, post approval studies, manufacturing and commercialization of approved products for all non-U.S. markets. Merck & Co., Inc., Kenilworth, NJ, USA is eligible to receive milestone payments and royalties on sales of Tildrakizumab.