Novartis Drug has been approved for the Treatment of Juvenile ERA and Psoriatic Arthritis

Novartis received a gift from Santa Claus in the shape of FDA clearance for Cosentyx in two indications: active ERA (enthesitis-related arthritis) in patients four years and older and active PsA (psoriatic arthritis) in patients two years and older.

The recent approvals represent the first time a biologic has been licensed for the treatment of ERA. Cosentyx is also the only biologic licensed for both PsA and ERA in pediatric patients in the United States. The most recent approvals are Cosentyx’s second and third in a pediatric population. In total, the FDA has given Cosentyx five thumbs up in the fields of rheumatology and dermatology.

The most recent Cosentyx approvals are based on the Phase III JUNIPERA research, which found that children with both indications who took Cosentyx had an 85 percent lower risk of flare in juvenile PsA patients and a 53 percent lower risk of flare in juvenile ERA patients. Cosentyx’s safety profile in pediatric patients was consistent with previously published Novartis data.Both ERA and juvenile PsA are autoimmune illnesses that are subgroups of juvenile idiopathic arthritis (JIA).

The swelling of joints, which leads to discomfort where the tendons and ligaments adhere to bone, is a symptom of ERA. Psoriasis of the skin and swelling of the joints are other symptoms of juvenile PsA.”The FDA approvals for JPsA and ERA come on the heels of Cosentyx’s approval as a first-line systemic treatment for pediatric psoriasis earlier this year, and they underscore Novartis‘ commitment to the pediatric community,” said Victor Bulto, head of Novartis Pharmaceuticals Corporation’s U.S. Pharmaceuticals.