The approval was based on data from the 2-year phase 3 JUNIPERA study that evaluated secukinumab in pediatric patients aged 2 to 17 years with a confirmed diagnosis of ERA or JPsA.
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
The update follows the FDA’s Drug Safety Communication, which was based on a completed review of a large randomized safety clinical trial evaluating tofacitinib in patients with rheumatoid arthritis.
The phase 3 COSMOS study evaluated the efficacy and safety of guselkumab in 285 adults with active PsA who had an inadequate response to anti-tumor necrosis factors.
Findings showed that treatment with secukinumab resulted in a 72% reduction in the risk of flare at week 104 compared with placebo.
ALLN-346 is an investigational, first-in-class, nonabsorbed, orally-administered enzyme that breaks down urate in the gastrointestinal tract.
The DISCOVER-2 trial included 739 biologic-naïve adults with active psoriatic arthritis who were treated and followed for approximately 2 years.
Zolgensma is an adeno-associated virus vector-based gene therapy.
The phase 3 ATOM study evaluated the efficacy and safety of abaloparatide in 228 men with osteoporosis.
The interchangeable biosimilar product may be substituted for the reference product by a pharmacist.
