Sun Pharma gets Australian health regulator’s nod for plaque psoriasis drug
22/09/2018
new delhi: Drug major Sun Pharmaceutical Industries Friday said it has received approval from the Australian health regulator Therapeutic Goods Administration's (TGA) for its speciality product, ILUMYA (tildrakizumab), used for the treatment of adults with plaque psoriasis.
"We are pleased to have received this approval and look forward to bringing ILUMYA to dermatologists and patients in Australia," Sun Pharma Business Head, Western Europe and Australia, Hellen De Kloet said in a statement.
The company said 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 like active tuberculosis.
"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.
ILUMYA is one of the key speciality products of Sun Pharma and it was approved by the US health regulator USFDA in March 2018 while the European Commission approved it in September 2018.
Sun Pharma said, 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 per cent between 2014 and 2016.
However, the number treated was less than 30 per cent of the severely affected population. The total PBS expenditure on biologicals for chronic plaque psoriasis (at published prices) was Australian Dollar 121 million in 2016.
Shares of Sun Pharma were trading 1.02 per cent lower at Rs 640.70 apiece on BSE.
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