Johnson & Johnson's (JNJ) Janssen Pharmaceutical said Friday said it asked the FDA for expanded approval of its Stelara drug to treat pediatric patients with juvenile psoriatic arthritis.
“The filing is supported by extrapolation of data from nine studies across both adult trials in active [juvenile psoriatic arthritis] and adult and pediatric studies in moderate to severe plaque psoriasis, totaling 3,997 patients evaluated across these closely associated diseases,” Janssen said.
“Data extrapolation is the process of estimating response, trends or effects based on previous observations from patients with closely related conditions.
“With the limited availability of pediatric patients for clinical-trial inclusion, researchers can extrapolate data from trials with adults to determine the potential efficacy and tolerability of a treatment for a pediatric population."
The New Brunswick, N.J., health-care titan expects a decision from the Food and Drug Administration late in 2022.
Morningstar analyst Damien Conover puts fair value for the stock at $167.
“Johnson & Johnson stands alone as a leader across the major health-care industries,” he wrote in July.
“The company maintains a diverse revenue base, a developing research pipeline, and exceptional cash-flow generation that together create a wide economic moat.
“J&J holds a leadership role in diverse health-care segments, including medical devices, over-the-counter products, and several pharmaceutical markets.
“Contributing close to 50% of total revenue, the pharmaceutical division boasts several industry-leading drugs, including immunology drugs Remicade, Stelara and Tremfya as well as cancer drugs Darzalex and Imbruvica."
J&J stock recently traded at $160.55, down 0.5%. It has slipped 7% in the past month.