The latest approvals mark the first time a biologic has been approved for ERA. Cosentyx is also the only biologic approved in the United States for both ERA and PsA in pediatric patients.
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Santa Claus delivered something a little early for Novartis in the form of an approval from the U.S. Food and Drug Administration for Cosentyx in two different indications, the treatment of active enthesitis-related arthritis (ERA) in patients four years and older and active psoriatic arthritis (PsA) in patients two years and older.
The latest approvals mark the first time a biologic has been approved for ERA. Cosentyx is also the only biologic approved in the United States for both ERA and PsA in pediatric patients. The latest approvals are the second and third approvals for Cosentyx in a pediatric population. In all, Cosentyx has received five nods of approval from the FDA in rheumatology and dermatology.
The latest approvals for Cosentyx are based on the Phase III JUNIPERA study, which showed that children diagnosed with both indications who received Cosentyx saw an 85% reduction in the risk of flare in juvenile PsA patients, and a 53% reduction of the risk of flare in juvenile ERA patients. The safety profile of Cosentyx in pediatric patients remained consistent with the known data for the Novartis medication.
ERA and juvenile PsA, both of which are subtypes of juvenile idiopathic arthritis (JIA), are autoimmune diseases. ERA is characterized by the swelling of joints that lead to pain where the tendons and ligaments attach to bone. Juvenile PsA also is characterized by a swelling of the joints, as well as skin psoriasis. If left untreated, the issue can lead to high levels of pain and disability.
Hermine Brunner, a physician with Cincinnati Children’s Hospital and trial lead, noted that some juvenile patients with ERA and PsA will continue to experience symptoms despite previous treatment options. Brunner said data from the JUNIPERA study shows that children treated with Cosentyx “demonstrated marked responses throughout the treatment period.” The approval is positive news for those juveniles who have not responded as well to available treatments.
“The FDA approvals for JPsA and ERA follow the approval of Cosentyx as a first-line systemic treatment for pediatric psoriasis earlier this year, and further reinforce the commitment of Novartis to the pediatric community,” Victor Bulto, head of U.S. Pharmaceuticals at Novartis Pharmaceuticals Corporation said in a statement. “Cosentyx is a proven medicine with a history of efficacy and safety across several systemic inflammatory conditions, with more than 500,000 patients treated worldwide since launch.”
Cosentyx is an interleukin-17A (IL-17A) inhibitor. IL-17A is produced by various cells from the innate immune system (which can be triggered by mechanical stress) and the adaptive immune system. Cosentyx has been approved to treat plaque psoriasis, active psoriatic arthritis and ankylosing spondylitis, a form of arthritis that affects the spine.
Novartis is also seeking regulatory approval for Cosentyx in this indication in Europe. The Swiss pharma giant filed regulatory submissions for Cosentyx in ERA and JPsA in Europe. A decision is expected to be made within the next few months, Novartis said.
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