FDA Approves Cosentyx for New Indications
Agency greenlights secukinumab’s use for pediatric Treatment of enthesitis-related arthritis and Juvenile psoriatic arthritis.
The FDA has approved secukinumab (Cosentyx, Novartis) for individuals aged 4 years or older with active enthesitis-related arthritis (ERA) and for individuals aged 2 years or older with active juvenile psoriatic arthritis (JPsA).
Secukinumab is the first biologic indicated for ERA and the only biologic treatment for both ERA and PsA in pediatric patients in the United States.
These are the second and third approvals for secukinumab in pediatric populations in the United States, and it has a total of 5 indications across rheumatology and dermatology.
“We are pleased to build on our strong heritage of bringing innovative treatments to young people living with rheumatic diseases, which began with the FDA approval of Ilaris. We are committed to bringing Cosentyx to this pediatric community globally as part of our ambition to expand Cosentyx to 10 indications in areas of high unmet need,” Todd Fox, global head of Medical Affairs Immunology, Hepatology, and Dermatology at Novartis, said in a statement.
The approved dosing of secukinumab for adolescents and children is 75 or 150 mg. It is administered subcutaneously by a pre-filled syringe or Sensoready pen every 4 weeks after the initial loading doses. Secukinumab can be administered by an adult caregiver outside a health care provider’s office, with appropriate guidance and instructions from a health care professional.
The approval is based on data from the phase 3 JUNIPERA study, which is a 2-year, 3-part, double-blind, placebo-controlled, randomized-withdrawal trial. The study included 86 individuals, aged 2 to 18 years, with a confirmed ERA or JPsA, according to a modified International League of Associations for Rheumatology classification criteria.
The primary endpoint was time to flare in the treatment period 2 (week 12 to week 104). The study results showed that individuals with active JPsA treated with secukinumab had a longer time to flare, showing about an 85% reduction in the risk of flare versus the placebo.
Individuals with active ERA who were treated with secukinumab also had a significantly longer time to flare, showing a 53% reduction in the risk of flare compared with the placebo.
The safety in the pediatric population is consistent with the known safety profile of secukinumab for the treatment of ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis, and PsAand.
“The findings from the Phase III JUNIPERA trial show that pediatric patients treated with secukinumab demonstrated marked responses throughout the treatment period. This approval is positive news for some patients who continue to struggle with painful symptoms like inflammation of the joints and swollen fingers and toes.”Hermine Brunner, MD, from Cincinnati Children’s Hospital, said in a statement.
In July 2020, secukinumab received approval in the European Union as a first-line systemic treatment for pediatric psoriasis for individuals aged 6 to 18 years and was recently approved in China and the United States. In 2021, secukinumab was also approved in Japan to treat both PsA and psoriasis in pediatric patients aged 6 years or older, as well as those with generalized pustular psoriasis.
Novartis has filed for a regulatory submission for secukinumab in ERA and JPsA in Europe with a decision expected in the coming months.
Novartis Cosentyx receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. Novartis. News release. December 22, 2021. Accessed January 4, 2022. Email.