Simponi Aria is claimed to be the first and only fully human anti-tumour necrosis factor (TNF)-alpha biologic agent for paediatric use in pJIA and active PsA
Janssen Pharmaceutica unit in Xi'an. (Credit: Vberger/Wikipedia.)
Janssen has received the US Food and Drug Administration (FDA) approval for Simponi Aria (golimumab) to treat active polyarticular juvenile idiopathic arthritis (pJIA) and active psoriatic arthritis (PsA) in children aged two years and above.
Simponi Aria is the first and only approved human anti-tumour necrosis factor (TNF)-alpha biologic agent, administered by intravenous (IV) infusion, claimed the company.
The drug targets both soluble and trans-membrane bioactive forms of human TNF-alpha, a protein that can cause inflammation, when overproduced in the body due to chronic inflammatory diseases.
Janssen R&D global head Mathai Mammen said: “This latest FDA approval of Simponi Aria for paediatric use in active pJIA and active PsA not only brings a new option to young patients living with these diseases but also adds to the growing body of evidence for this treatment.
“For more than 20 years, we at Janssen have been committed to researching anti-TNF biologic agents for immune-mediated diseases and are encouraged to expand treatment options for these patients.”
According to the company, arthritis continuing for at least six weeks before the age of 16 years is called juvenile idiopathic arthritis (JIA). An inflammation in more than four joints, similar to adult rheumatoid arthritis (RA), is called pJIA
PsA in paediatric patients is a rare disorder, characterised by both joint inflammation and skin lesions associated with psoriasis resembling adult PsA.
Results from Phase 3 GO-VIVA clinical trial supported the FDA approval of Simponi Aria
The FDA approval was supported by results from the Phase 3 GO-VIVA clinical trial, an open-label study in paediatric pJIA patients, aged between two and 17 years, regardless of methotrexate treatment, for at least two months.
In the Phase 3 study, the pharmacokinetic (PK) exposure of Simponi Aria was consistent with that of two other Phase 3 clinical trials of the drug in adult patients with active PsA and moderately to severely active RA.
Also, Simponi Aria has shown an efficacy that was generally consistent with responses in adult patients with RA. Adverse reactions in the study were consistent with the established safety profile of the drug in adult patients with RA and PsA.
Cincinnati Children’s Hospital Medical Centre paediatric rheumatology Joseph Levinson professor Daniel J Lovell said: “Due to the limited availability of paediatric patients for inclusion in clinical trials, it can be challenging to build clinical studies for this young patient population.
“Given these challenges, I am pleased to see Janssen advance the approval of a new treatment option for paediatric patients with pJIA and PsA, an important milestone in the treatment of these complex, heterogeneous diseases.”
Also, the company has filed a New Drug Application (NDA) with the FDA, seeking approval for UPTRAVI (selexipag) as an intravenous (IV) injection treatment for pulmonary arterial hypertension (PAH).