Sun Pharma Gets USFDA Approval

The approval expands ILUMYA’s use to adults with active psoriatic arthritis in the United States.

Sun Pharmaceutical Industries Ltd has received approval from the United States Food and Drug Administration (USFDA) for an expanded use of its drug ILUMYA to treat adults with active psoriatic arthritis.

The company said the US regulator approved its supplemental Biologics License Application for ILUMYA, also known as tildrakizumab-asmn.

The approval expands the use of the IL-23 inhibitor beyond its existing indication for moderate-to-severe plaque psoriasis.

ILUMYA is administered exclusively by healthcare providers. Sun Pharma said the expanded approval provides an additional treatment option for adults with active psoriatic arthritis, particularly those who may be unable to self-administer medication or benefit from regular in-office care.

The company’s North America CEO, Rick Ascroft, described the approval as an important milestone in expanding the company’s portfolio of treatments for psoriatic diseases.

Psoriatic arthritis is a chronic immune-related condition that can cause joint pain, swelling and stiffness, potentially resulting in permanent joint damage.

ILUMYA previously received USFDA approval in 2018 for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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