Sep 21: Sun Pharmaceutical Industries Ltd on Friday announced that the company 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 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 ILUMYA, and in patients with clinically important active infections, e.g. active tuberculosis,” Sun Pharma said.
“We are pleased to have received this approval and look forward to bringing ILUMYA 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.
According to Sun Pharma, ILUMYA was approved by USFDA in March 2018 while the European Commission approved it in September 2018.