Sun Pharmaceutical today announced that one of its wholly-owned subsidiaries has received approval from the
ILUMYA is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of IL-23 and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of proinflammatory cytokines and chemokines.
ILUMYA is one of the key specialty products of Sun Pharma and it was approved by the
The MHLW approval of ILUMYA for the treatment of 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). 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 ILUMYA 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% of patients.
After a 64-week base study of reSURFACE 1, a total of 120 Japanese patients entered the reSURFACE 1 extension study and 101 patients completed the extension study for 148 weeks.
About Psoriasis
Psoriasis is a chronic immune disease that appears on the skin, affecting approximately 125 million people worldwide2. The non-contagious disorder speeds the growth cycle of skin cells2 and results in thick scaly areas of skin3. The most common form, affecting about 80 to 90 percent of people with psoriasis, is called plaque psoriasis4. It appears as red, raised areas of skin covered with flaky white scales which may be itchy and painful and can crack and bleed3. Twenty percent of people with plaque psoriasis are considered moderate-to-severe, and many continue to struggle with the ongoing, persistent nature of this chronic disease.
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Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and
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