The US regulator has accepted Sun’s supplemental Biologics License Application (sBLA) for review, the company said in a statement on Monday.
The regulatory acceptance marks a significant step for Sun in its ambition to strengthen its innovative medicines pipeline.
The application seeks approval to use Ilumya (tildrakizumab) for the treatment of adults with active psoriatic arthritis, a chronic autoimmune condition that affects joints and is often associated with psoriasis. The regulator has set a target action date of October 29.
If approved, Ilumya would expand beyond its current indication for moderate-to-severe plaque psoriasis to address a broader segment of patients suffering from psoriatic disease.
Rick Ascroft, CEO of Sun Pharma North America, said: “For many people living with psoriatic disease, joint symptoms often add another layer of burden.” “As we continue to strengthen Sun Pharma’s innovative portfolio, we look forward to working with the FDA throughout the review process.”
According to estimates, roughly one in three patients with psoriasis eventually develops psoriatic arthritis.The submission to the regulator is supported by results from the INSPIRE-1 and INSPIRE-2 Phase 3 clinical trials, which evaluated the drug’s efficacy and safety in adults with active psoriatic arthritis over a 52-week period.
Globally, Ilumya has received marketing approvals from more than 55 health authorities, including in India, Japan, EU, China, Australia and Canada.
