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Sun Pharma Announces Australian TGA Approval of ILUMYA

Sun Pharmaceutical Industries Ltd. announced that Sun Pharma has received the Australian Therapeutic Goods Administration (TGA) approval for its specialty 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 IL23 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 percent between 2014 and 2016. However, the number treated was less than 30 percent of the severely affected population. The total PBS expenditure on biologicals for chronic plaque psoriasis (at published prices) was AUSD 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 multicenter, 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. The most common adverse reactions observed with ILUMYATM in the pooled data from one Phase 2 and two Phase 3 studies in psoriasis patients for the placebo-controlled period (16 weeks for the Phase 2 study and 12 weeks for the Phase 3 studies) were nasopharyngitis, headache, and site injection pain. Most adverse reactions were considered mild and no adverse reaction led to discontinuation of treatment in >1 percent of patients. – Medical Buyer Bureau

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