The FDA on Wednesday gave approval to a novel treatment for psoriasis that could provide relief to the millions of people suffering from the skin condition.
The agency awarded approval to Johnson & Johnson‘s oral pill Icotyde for use in people 12 and older with moderate to severe plaque psoriasis.
The new pill is designed to mimic existing treatments for the 8 million Americans with psoriasis but without the need for needles and injections.
Psoriasis is an autoimmune condition that causes skin cells to build up rapidly. This leads to itchy, flaky, scaly and inflamed skin patches, or plaques. It is caused by genetics, as well as environmental triggers like stress or infections.
While it isn’t life-threatening, it can cause extremely uncomfortable symptoms, including itching and burning skin, dry and cracked skin that can sometimes bleed, and swollen and painful joints.
Sufferers also often experience anxiety and embarrassment surrounding their condition, causing significant mental health distress in addition to physical symptoms.
Current treatment options include topical steroid creams, using artificial light to slow skin cell growth and injections, which can cost thousands each year even with insurance coverage and are less convenient than a daily pill.
Icotyde is the first and only oral treatment for psoriasis that targets the Interleukin-23 (IL‑23) receptor, a protein complex on immune cells that binds Il-23 cytokines, molecules that induce inflammation. While that inflammation helps fight infections, overactive levels lead to autoimmune diseases such as psoriasis.
The FDA has approved a new oral pill for psoriasis, an autoimmune condition that causes skin cells to build up rapidly, leading to itchy, flaky, scaly and inflamed skin patches, or plaques (stock image)
Dr John Reed, executive vice president, R&D, innovative medicine at J&J, said: ‘the approval of Icotyde represents a pivotal moment for people with plaque psoriasis.
‘At Johnson & Johnson, we are harnessing our scientific expertise to transform cutting-edge science into meaningful solutions for patients. Icotyde is a fundamentally different treatment with the potential to redefine what physicians and patients can expect from psoriasis treatment.’
The FDA’s approval follows positive results from four phase 3 clinical trials including more than 2,500 patients. The studies found that approximately 70 percent of patients achieved clear or almost clear skin after 16 weeks.
The research has shown Icotyde has a favorable safety profile with minor side effects, which include headache, nausea, cough, fungal infection and tiredness.
It’s still unclear if the drug is safe for pregnant or breastfeeding women.
J&J has not yet disclosed the list price for Icotyde, but injectable drugs that target IL-23 can run up to $100,000 per year. It’s also unclear if it will be covered by insurance.
Icotyde pills, pictured above, were approved by the FDA for psoriasis
Dr Linda Stein Gold, director of dermatology clinical research at Henry Ford Health, said: ‘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.
‘With new guidance from the International Psoriasis Council that clarifies when to move beyond cycling on topical treatments to systemic therapy, an innovative option like Icotyde is a potential game‑changer for many adult and adolescent patients.’
Psoriasis usually appears between ages 10 and 35, with peaks between ages 20 and 30 and 50 and 60. About one in three patients have a family member with the condition.
Flare-ups are often triggered by stress, skin injuries such as cuts or scrapes, infections and cold weather. Lifestyle factors that cause inflammation, such as smoking and heavy alcohol consumption, can also worsen symptoms.
