Sun Pharma Japan, a wholly owned subsidiary of Sun Pharmaceutical Industries, has received approval from the Ministry of Health, Labour and Welfare (MHLW), Japan for ILUMYA (tildrakizumab) for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies. Japan has approximately 4,30,000 people currently suffering from psoriasis.
Junichi Nakamichi, country head, Sun Pharma Japan, said, “ILUMYA is the first innovative drug that Sun Pharma plans to launch in Japan. It was extensively tested in Japanese patients as part of ILUMYA’s global clinical development programme.”
“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 over four years with low rates of severe infections, malignancies and MACEs,” he added.
ILUMYA is one of the key specialty products of Sun Pharma and it was approved by the USFDA in March 2018 while the European Commission approved it in September 2018. The MHLW approval of ILUMYA for the treatment of plaque psoriasis was supported by data from the pivotal Phase-3 reSURFACE clinical development programme, the company said in a statement.
Source Name – The Hindu