FDA Approves Treatment for Moderate-to-Severe Plaque Psoriasis

Officials with the FDA have approved tildrakizumab-asmn, (Ilumya, Sun Pharma) for treating adults with moderate-to-severe plaque psoriasis, according to the manufacturer. In a statement released Wednesday announcing the approval, SunPharma said the medication is intended for patients who are candidates for systemic therapy or phototherapy.¹

Psoriasis is a chronic dermatologic disease that develops when a person’s immune system sends faculty signals, causing skins cells to grow too quickly.² According to the American Academy of Dermatology, the body does not shed the excess skin cells, which causes them to build on the surface of the skin and creating raised, reddish patches with a white coating. Plaque psoriasis is the most common form of the condition with patches most often appearing on the knees, elbows, lower back and scalp.³ These patches are often itchy and painful, and can crack and bleed.³

The approval of tildrakizumab-asmn was based on positive findings in the phase 3 reSURFACE clinical development program. In reSURFACE 1 and reSURFACE 2, 926 adults with moderate-to-severe plaque psoriasis were treated with tildrakizumab-asmn or placebo.

Sun Pharma reported that both trials met their primary efficacy endpoints of significant clinical improvement with tildrakizumab-asmn 100-mg compared with placebo, as measured by achieving Psoriasis Area Sensitivity Index 75 (PASI 75) and a Physician’s Global Assessment (PGA) score of clear or minimal at week 12.

The researchers found that 74% of patients in reSURFACE 1 achieved PASI 75 at week 28 after 3 doses. Approximately 84% of patients who continued therapy maintained this level of skin clearance at 64 weeks compared with 22% of patients who were re-randomized to receive placebo, according to the release.

Additionally, 69% of patients who achieved a PGA score of clear or minimal at 28 weeks maintained this response at 64 weeks compared with 14% of patients who were re-randomized to receive placebo.

The statement noted that some patients treated with tildrakizumab-asmn experienced angioedema and urticaria. The drug may also increase the risk of infection; thus, the risks and benefits of treatment should be considered in patients with a chronic infection or a history of recurrent infections, according to the release.

The most common adverse events include upper respiratory infections, injection site reactions, and diarrhea.

“With the approval of ILUMYA and our long-standing commitment in dermatology, we are focused on making a difference for people living with moderate-to-severe plaque psoriasis,” said Abhay Gandhi, President and CEO of North America, Sun Pharma, in a press release. “We are committed to working with all relevant stakeholders to make ILUMYA available to appropriate people with plaque psoriasis.”

Ilumya is administered at a dose of 100 mg by subcutaneous injection every 12 weeks, after the completion of initial doses at weeks 0 and 4. The drug is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipents.¹ Ilumya works by selectively binding to the p19 subunit of IL-23 and inhibiting its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines, according to SunPharma.

References

• Sun Pharma Announces US FDA Approval of ILUMYA™ (tildrakizumab-asmn) for the Treatment of Moderate-to-Severe Plaque Psoriasis [news release]. Mumbai, India and Princeton, NJ. SunPharma. www.prnewswire.com/news-releases/sun-pharma-announces-us-fda-approval-of-ilumya-tildrakizumab-asmn-for-the-treatment-of-moderate-to-severe-plaque-psoriasis-300617454.html. Published March 21, 2018.
• Psoriasis. American Academy of Dermatology. www.aad.org/public/diseases/scaly-skin/psoriasis#symptoms. Accessed March 21, 2018.
• Psoriasis Types. National Psoriasis Foundation. www.psoriasis.org/about-psoriasis/types/plaque. Accessed March 21, 2018.