Sun Pharma gets Japanese Ministry of Health approval for Ilumya

One of the wholly-owned subsidiaries of Sun Pharmaceutical Industries has been granted approval from Ministry of Health, Labour and Welfare (MHLW), Japan for Ilumya (Tildrakizumab) for the treatment of plaque psoriasis in adult patients. It had received United States Food and Drug Administration (USFDA) approval in March 2018 and European Commission’s approval in September 2018.

Psoriasis is a chronic immune disease that appears on the skin. The most common form, affecting about 80 to 90 per cent of people with psoriasis, is called plaque psoriasis. The non-contagious disorder speeds the growth cycle of skin cells and results in thick scaly areas of skin. It appears as red, raised areas of skin covered with flaky white scales, which may be itchy, painful, crack and bleed.

Ilumya is a humanised lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of IL-23 and inhibit its interaction with IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. A three-phase reSURFACE clinical development program was conducted after which, the company got the nod from MHLW. In this program, tests were conducted extensively in Japanese patients.

The company stated that the drug offers a new treatment option with only one injection every 12 weeks for Japanese patients, who struggle everyday with the chronic nature of plaque psoriasis. It showed sustained efficacy for over four years and has safety profiles with low rates of severe infections, malignancies and MACEs.

Sun Pharma has commercialised Ilumya in USA and Australia in FY19. The company received good initial response for the product and would ramp-up its sales in US market over the next few years. With this latest approval, the company would be able to further contribute in the large US$ ~15 billion global psoriasis market. The company plans to commercialise this product, in other key markets, either on its own or through partnerships.

On Monday, the stock of Sun Pharma opened at Rs 476.90 and in the early morning session, it surged 1.5 per cent to Rs 487.25 from its previous close of Rs 479.95 on BSE.