The shares of Sun Pharmaceutical Industries Ltd. gained over 2%, extending a four-day gaining streak after the company received approval from the US Food and Drug Administration (FDA) for its drug ILUMYA to treat adults with active psoriatic arthritis, a painful joint condition.
The decision extends a drug first cleared for a skin condition to a joint disease.
The FDA approved a supplemental Biologics License Application, which sought approval to add a new use for ILUMYA (tildrakizumab-asmn), according to a regulatory filing on Friday, October 30.
“FDA approval of ILUMYA for adults with active psoriatic arthritis represents another important innovative medicine milestone for Sun Pharma and builds on the established clinical experience of ILUMYA in plaque psoriasis,” said Rick Ascroft, North America CEO, Sun Pharma.
Ascroft said ILUMYA, an interleukin-23 (IL-23) inhibitor given by healthcare professionals, was an option for adults with active psoriatic arthritis who could not self-administer treatment or preferred regular in-office care.
Interleukin-23 is a signalling protein in the immune system that helps regulate inflammation and immune responses.
Psoriatic arthritis is a long-term immune disease that causes pain, swelling and stiffness in joints and entheses, the sites where tendons and ligaments connect to bones. It can lead to permanent joint damage.
Around 2.4 million Americans suffered from the condition, and about one in three psoriasis patients developed joint involvement, the filing said.
ILUMYA first won US FDA approval in 2018 for adults with moderate to severe plaque psoriasis who were suitable for systemic therapy, which acts on the whole body, or phototherapy, which uses light.
The approval rested on the Phase 3 INSPIRE-1 and INSPIRE-2 studies, according to the filing. The randomised studies tested a 100 mg dose of tildrakizumab in adults with active psoriatic arthritis and confirmed significant effectiveness after only two doses at week 24, according to the filing.
The results matched the medicine’s established safety profile and showed no new safety signals. Upper respiratory tract infections and COVID-19 were the most common side effects in the studies.
ILUMYA was the first biologic to receive the National Psoriasis Foundation Seal of Recognition, the filing said. It won approval in India, Australia, Canada, China and Japan, and in Europe as ILUMETRI, marketed by Almirall.
Market Reaction
The shares of Sun Pharma gained 2.12% % as of 9:20 am on Friday. The company’s shares have gained almost 4.49% % in the year-to-date period with additional gains of almost 5.57% % in the trailing 12-month period.
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Sun Pharma shares extend 4-day rally after USFDA approval for ILUMYA in arthritis patients