Health and Me

Rachel V Thomas

Icotyde: US FDA Approves Johnson & Johnson's Pill For Psoriasis

The US Food and Drug Administration has approved Johnson &amp; Johnson's once-daily pill for <a href="https://www.healthandme.com/health/psoriasis">psoriasis</a> -- a chronic skin disease.

Icotyde is an interleukin-23 (IL-23) receptor antagonist approved for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older.

Psoriasis is an autoimmune condition that causes rough patches of skin. The new once-daily pill has been found safe and also delivers complete skin clearance.

In the statement, J&amp;J said that the approval will lead to a first-line systemic treatment of plaque psoriasis with a targeted oral peptide.

“Icotyde delivers something unique in psoriasis treatment – combining skin clearance with a favorable safety profile in a once‑daily pill, making it an easy addition to a patient’s routine,” said Linda Stein Gold, Director of Dermatology Clinical Research at Henry Ford Health.

The novel pill also aligns with the recent International Psoriasis Council guidance that suggests transitioning to systemic therapy if two cycles of topical medications applied for four weeks fail to bring meaningful improvement.

Icotyde will prove to be “a potential game‑changer for many adult and adolescent patients”, Gold said.

The FDA’s approval is based on an unprecedented body of evidence from the phase three clinical trial, which simultaneously evaluated Icotyde in adults and adolescents, and found it a safe and effective oral pill, and also better than injectables and topical creams.

According to analysts from Wall Street, Icotyde has "blockbuster potential," and the once-daily medication could capture significant market share from injectables like Skyrizi and J&amp;J's own Tremfya, Reuters reported.

J&amp;J is also studying the ⁠drug, chemically known as icotrokinra, for ulcerative colitis, psoriatic arthritis, and Crohn's disease.

Psoriasis develops when the body makes skin cells too quickly. It causes skin cells to pile up and form visible patches or spots on the skin, which may be itchy or painful.

The condition, however, is not contagious.

According to the National Psoriasis Foundation, the skin disease affects 8 million Americans and more than 125 million people worldwide.

The condition impacts physical comfort and quality of life, especially when lesions are on visible or sensitive areas.

The plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales. They can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.

Icotyde is currently approved in the US for the treatment of people with moderate-to-severe plaque. It can be used by 

<ul><li>adults, and pediatric patients 12 years of age and older</li><li>who weigh at least 40 kg.</li></ul>

Health Conditions A-Z

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Psoriasis

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The US Food and Drug Administration has approved Johnson & Johnson's once-daily pill for psoriasis -- a chronic skin disease. Icotyde is an interleukin-23 (IL-23) receptor antagonist approved for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older. Psoriasis is an autoimmune condition that causes rough patches of skin. The new once-daily pill has been found safe and also delivers complete skin clearance. In the statement, J&J said that the approval will lead to a first-line systemic treatment of plaque psoriasis with a targeted oral peptide. “Icotyde delivers something unique in psoriasis treatment – combining skin clearance with a favorable safety profile in a once‑daily pill, making it an easy addition to a patient’s routine,” said Linda Stein Gold, Director of Dermatology Clinical Research at Henry Ford Health. The novel pill also aligns with the recent International Psoriasis Council guidance that suggests transitioning to systemic therapy if two cycles of topical medications applied for four weeks fail to bring meaningful improvement. Icotyde will prove to be “a potential game‑changer for many adult and adolescent patients”, Gold said. The FDA’s approval is based on an unprecedented body of evidence from the phase three clinical trial, which simultaneously evaluated Icotyde in adults and adolescents, and found it a safe and effective oral pill, and also better than injectables and topical creams. According to analysts from Wall Street, Icotyde has "blockbuster potential," and the once-daily medication could capture significant market share from injectables like Skyrizi and J&J's own Tremfya, Reuters reported. J&J is also studying the ⁠drug, chemically known as icotrokinra, for ulcerative colitis, psoriatic arthritis, and Crohn's disease. What Is Psoriasis? Psoriasis develops when the body makes skin cells too quickly. It causes skin cells to pile up and form visible patches or spots on the skin, which may be itchy or painful. The condition, however, is not contagious. According to the National Psoriasis Foundation, the skin disease affects 8 million Americans and more than 125 million people worldwide. The condition impacts physical comfort and quality of life, especially when lesions are on visible or sensitive areas. The plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales. They can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso. Who Can Use Icotyde Icotyde is currently approved in the US for the treatment of people with moderate-to-severe plaque. It can be used by adults, and pediatric patients 12 years of age and olderwho weigh at least 40 kg.