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Ilumya gains FDA approval for treating moderate-to-severe plaque psoriasis

The US Food and Drug Administration (FDA) has approved Ilumya (tildrakizumab-asmn) for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The Sun Pharma drug was granted approval following two Phase 3 clinical trials featuring 926 patients. 

“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 chief executive officer, North America, Sun Pharma.

Psoriasis is a chronic immune condition characterized by thick scaly areas of skin. The majority of cases are plaque psoriasis, which accounts for around nine out of ten instances of psoriasis. It manifests as a red raised area of skin with flaky white scales that n can be itchy and painful and leave to cracking and bleeding. A recent National Health and Nutrition Examination Survey by the Centers for Disease Control and Prevention (CDC) estimated around 6.7 million adults in the United States suffer from psoriasis. 

Ilumya is administered in 100mg doses by a subcutaneous (under the skin) injection every 122 weeks. The drug is contraindicated in patients with a history of serious hypersensitivity to tildrakizumab. Some patients treated with the drug in the trial experienced angioedema and urticaria and it may also increase the risk of infection, according to Sun Pharma. Common adverse events included upper respiratory tract infections, injection site reactions, and diarrhea.

Other Treatments for Psoriasis

Plaque psoriasis is considered an autoimmune disease in which the immune system attacks healthy skin cells as if fighting an infection, causing new cells to grow faster than normal and causing thick build-ups of skin cells. Risk factors include a family history of psoriasis, injury to the skin, sunburn, certain medication, infections, and high levels of stress. 

It is commonly treated with topical medications such as corticosteroids. Certain systemic drugs targeting the immune system are also used to treat psoriasis, such as Humira (adalimumab) and Remicade (infliximab).