Sun Pharma shares gained 2.12% as of 9:20 am on Friday, extending a four-day gaining streak following the US FDA approval for ILUMYA. According to CNBC TV18, 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. The stock movement reflects investor confidence in the drug's expanded market potential beyond its original skin treatment indication. The approval represents a significant milestone for Sun Pharma's specialty portfolio, with the company's innovative medicines contributing around 20% of its sales.
Sun Pharmaceutical Industries announced on Friday that the US Food and Drug Administration (FDA) has approved ILUMYA (tildrakizumab-asmn) for treating adults with active psoriatic arthritis. According to CNBC TV18, the FDA approved a supplemental Biologics License Application that sought approval to add this new use for ILUMYA. This approval expands the drug's use beyond its original indication for moderate-to-severe plaque psoriasis, which was approved in the US in 2018. The drug is an interleukin-23 (IL-23) inhibitor administered exclusively by healthcare professionals. As per CNBC TV18, Rick Ascroft, North America CEO of Sun Pharma, noted that the FDA approval represents another important innovative medicine milestone for the company and builds on the drug's established clinical experience in plaque psoriasis.
The latest approval is supported by data from two Phase 3 clinical trials, INSPIRE-1 and INSPIRE-2, which evaluated the drug's efficacy and safety in adults with active psoriatic arthritis. According to CNBC TV18, 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. The company stated that safety findings were consistent with ILUMYA's established safety profile, with no new safety signals identified. The results matched the medicine's established safety profile and showed upper respiratory tract infections and COVID-19 were the most common side effects in the studies. As reported by CNBC TV18, ILUMYA was the first biologic to receive the National Psoriasis Foundation Seal of Recognition.
According to the company data cited by CNBC TV18, around 2.4 million Americans suffered from psoriatic arthritis, with about one in three psoriasis patients developing joint involvement. 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, potentially leading to permanent joint damage. The condition can develop at any age and irrespective of the severity of psoriasis, making it a significant healthcare challenge. The label expansion for ILUMYA strengthens Sun Pharma's position in the high-margin North American specialty market by broadening treatment indications into rheumatology, expanding the company's commercial addressable market while leveraging existing specialty delivery and clinical infrastructure.
ILUMYA is also approved for moderate-to-severe plaque psoriasis in India, Australia, Canada, China and Japan, and in Europe as ILUMETRI by Almirall. According to CNBC TV18, Ascroft noted that 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. The drug is a monoclonal antibody designed to target the p19 subunit of IL-23, blocking its interaction with the IL-23 receptor to inhibit pro-inflammatory cytokines and chemokines. The drug may increase the risk of infections, and patients must be evaluated for tuberculosis before starting treatment, with the company emphasizing that the drug is administered by a healthcare provider.
