Beijing News (Reporter Wang Kala) October 29 is World Psoriasis Day. Novartis China announced that the innovative biologic Secukinumab (300mg无忧随心笔 and 75mg pre-filled injection) has been approved by the National Medical Products Administration for expanded use in pediatric psoriasis patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, without weight restrictions.
With the approval of the new specifications, secukinumab has become the only fully human interleukin inhibitor in China to be approved for three specifications (300mg, 150mg, 75mg).
Psoriasis is an immune-related chronic, recurrent, inflammatory, and systemic disease, with over 6.5 million patients in China. As the disease currently has no cure, patients need to adhere to standardized and appropriate treatment plans over the long term to achieve good control of their condition and reach complete clearance of skin lesions. In actual clinical practice, sticking to the treatment poses a significant challenge for patients.
Secukinumab is the world's first and only fully human monoclonal antibody targeting IL-17A, capable of specifically neutralizing IL-17A from various sources and inhibiting its pro-inflammatory effects, offering a breakthrough treatment option for patients with moderate to severe plaque psoriasis. To date, secukinumab has been approved in multiple countries and regions, including the United States and EU member states, for the treatment of pediatric and adult psoriasis, psoriatic arthritis, ankylosing spondylitis, and radiographic-negative axial spondyloarthritis. It is also the only biologic agent approved for pediatric psoriasis treatment in the EU, the US, and China, and is recommended by several international latest guidelines as a therapeutic option for psoriasis.
In June 2020, Novartis' Secukinumab 150mg Sensoready Pen was approved in China, allowing patients to self-inject at home after guidance from a physician. The standard treatment dose for most psoriasis patients is 300mg per session, requiring two 150mg subcutaneous injections. The newly approved 300mg Sensoready Pen simplifies the process from two 150mg injections to a single 300mg injection, improving patient adherence to treatment. Studies show that the efficacy and safety of the 300mg Sensoready Pen are equivalent to two 150mg injections, with an incidence of adverse reactions at the injection site of less than 0.1%.
In terms of pediatric indications, in 2021, after secukinumab was approved for pediatric and adolescent psoriasis, children weighing less than 50kg were restricted from using it due to their weight. Many parents have been hoping for a smaller specification product to be approved and launched as soon as possible. The approval of the 75mg pre-filled injection has expanded the range of pediatric psoriasis indications. Studies have shown that adverse events with secukinumab treatment for psoriasis at 12 weeks were similar to those of placebo. After continuous treatment for 52 weeks, no new or unexpected safety issues were found in either the low-dose or high-dose treatment groups.
To date, secukinumab has been successively approved in China for the treatment of "adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as pediatric patients aged 6 years and above weighing ≥50kg" and "adult patients with ankylosing spondylitis who have had an inadequate response to conventional therapy," and was officially included in the National Reimbursement Drug List (NRDL) in 2020.
Proofread by Lu Qian