FDA Approves ILUMYA™ for Psoriasis

The US Food and Drug Administration (FDA) has approved the new drug, ILUMYA™, for treatment of plaque psoriasis. ILUMYA, an injectable, has demonstrated significant effectiveness in clinical trials. The announcement was made by Sun Dermatology, a division of Sun Pharmaceuticals. The Company, headquartered in Mumbai India, and Princeton New Jersey, specializes in developing pharmacological treatments in the dermatology space, including for plaque psoriasis.

What is plaque psoriasis

Psoriasis is a chronic, autoimmune dermatological disorder. There are several forms, the most common of which is called plaque psoriasis. It is so called because plaques are patches of raised, red, dry, and sometimes scaly skin. (https://plaquepsoriasis.com/what-is-psoriasis/) It is not contagious but appears as a visible, sometimes irritating skin condition. Affected areas can be itchy, and may crack or bleed. Dealing with psoriasis can be a persistent struggle because there is no cure. However, new drugs are more effectively treating the condition for longer durations.¹

80-90% of all people with psoriasis have plaque psoriasis. The condition causes cells to proliferate, to grow too quickly. They most commonly appear on elbows, knees, scalp and the lower back. Traditional treatments for psoriasis include over-the-counter and prescription ointments, and creams applied directly to the affected areas as well as systemic oral medications and injectable medications that directly impact immune function and the rate at which the affected cells multiply. There is also light therapy, which exposes skin to UV light either through natural sunshine in certain specific locales or through a specialized light box.

New treatments

The newest drug, ILUMYA (tildrakizumab-asmn), has been approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ILUMYA works by inhibiting the release of pro-inflammatory proteins.

Trials in 2 different centers yielded data from Phase 3 trials and the reSURFACE clinical development program. 926 adult patients were treated, approximately 2/3 with the drug and 1/3 with a placebo. Study results published in the July 2017 edition of The Lancet revealed significant clinical improvement for patients using ILUMYA compared to the placebo. The results met the efficacy endpoints in both studies and were classified and measured by a minimum of 75 percent clear skin after two doses and 12 weeks.¹ Significant clinical improvement was measured at week 28 and 3 doses and even more improvement was registered in those who continued the treatment regimen after 64 weeks.²

Safety

ILUMYA is considered safe to use in adults. The most common side effects of ILUMYA are upper respiratory infections, tiredness and diarrhea. Other side effects include angioedema, a swelling of the lower layer of skin and tissue just under the skin or mucous membranes, and urticaria, hives. As with most therapeutic agents, the risks and benefits of using ILUMYA should be considered in people with chronic or recurrent infections.

People with hypersensitive reactions should stop taking ILUMYA immediately, and seek medical attention. Taking ILUMYA may increase your risk for infection so doctors recommend that you not start the medication when you have an active infection, or are immune-suppressed. Like with most biologics that treat psoriasis, testing for TB should be done before beginning treatment.¹