J&J Simponi Aria Gets FDA Nod for Pediatric Use in Arthritis
Johnson & Johnson JNJ announced that the FDA has granted approval to its TNF inhibitor, Simponi Aria for the treatment of children 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). The FDA also expanded Simponi Aria’s active psoriatic arthritis (PsA) indication use for pediatric patients 2 years and older. Simponi Aria is presently approved as a 30-minute intravenous infusion for moderately-to-severely active rheumatoid arthritis, active PsA and ankylosing spondylitis in adults.
The approval of Simponi Aria for pediatric use in active pJIA and active PsA was based on data from the GO-VIVA phase III study. The polyarticular form of JIA is most common, which causes inflammation in more than four joints. PsA in pediatric patients is a sub-type of JIA characterized by both joint inflammation and skin lesions associated with psoriasis.
So far this year, J&J’sshares have risen 2.1% against the industry’s 1% decrease.
Simponi Aria, a key drug in J&J’s immunology franchise, recorded sales of $1.08 billion in the first half of 2020. Other important drugs in this franchise are Stelara and Remicade while a key new drug is Tremfya. J&J markets Remicade in partnership with Merck MRK.
Some successful TNF inhibitor drugs currently marketed are AbbVie’s ABBV Humira and Amgen AMGN/Pfizer’s Enbrel.
J&J also filed a new drug application seeking approval of its pulmonary arterial hypertension (PAH) drug Uptravi as an injection for intravenous (IV) use in patients who are unable to take the currently marketed oral formulation of the drug. The NDA was based on data from a phase III study, which evaluated safety and tolerability of temporarily switching from oral Uptravi to Uptravi IV in patients with PAH, and then transitioning back to the initial oral dose. Uptravi was added to J&J’s product portfolio with the 2017 acquisition of Actelion.
J&J currently has a Zacks Rank #4 (Sell).
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