The Food and Drug Administration approved the use of Enbrel for pediatric patients suffering from moderate to severe forms of skin psoriasis, after a panel of medical experts gave its nod to the drug.
From the FDA panel comprised of outside medical experts, the drug did not get a unanimous vote in its favor; seven voted in favor, five against while one abstained.
Enbrel is already an FDA approved treatment for adult and children’s rheumatoid arthritis, as well as adult psoriasis. The FDA panel expressed concerns about chances of the drug increasing malignancy and serious infections like tuberculosis. These were similar to concerns it raised regarding a proposed drug by Johnson & Johnson also for pediatric psoriasis, which got a unanimous approval from the panel.
Amgen, the company that manufactures the drug Enbrel, estimates that there are about 17,500 children who suffer from moderate to severe skin psoriasis. Often a debilitating disease, psoriasis is a chronic inflammatory skin disease characterized by silvery white scars whose most common form in children is plaque psoriasis.
Most psoriasis patients irrespective of age are treated topically with emollients such as topical corticosteroids to decrease scaling and itching. This treatment is found adequate for sufferers from mild psoriasis but does not help in moderate or severe cases.
Enbrel and Johnson & Johnson’s Remicade are under investigation by the FDA to see if they increase the risk of cancer in children and adolescents. Reports of 30 cases of cancer in children, who took the drugs over the last 10 years, are being looked into and the FDA intends to submit its report within six months.