Janssen Submits Application Seeking U.S. FDA Approval of STELARA ® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis
HORSHAM, PENNSYLVANIA, October 8, 2021 – The Janssen Pharmaceutical Companies of Johnson &Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).The filing is supported by extrapolation of data from nine studies across both adult trials in active PsA and adult and pediatric studies in moderate to severe plaque psoriasis, totaling 3,997 patients evaluated across these closely associated diseases. 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. A decision from the U.S. FDA is anticipated in late 2022.“As children and their families manage the debilitating symptoms of juvenile psoriatic arthritis, it is critical that their physicians have a breadth of treatment options to consider,” said Alyssa Johnsen, M.D., Ph.D., Vice President, Rheumatology Disease Area Leader, Janssen Research &Development, LLC. “With this latest submission, we’re excited to work with the U.S. FDA to evalu...
I have been told the following by my asc. Anyone else ever come across this? “27096 is not reimbursed by Medicare when performed in an ASC. G0260 replaces 27096”
Conclusions Genomics will continue to drive advances in CVD prevention and management, and equitable progress is imperative. Nursing should leverage the public's trust and its widespread presence in clinical and community settings to prevent the worsening of CVD disparities among African Americans.
Background Cardiovascular disease is a significant health problem in the United States, attributed to more than 30% of all deaths annually. Anxiety has been associated with cardiovascular disease risk and is thought to be associated with cardiovascular disease risk through inflammatory pathways. Objective The purposes of this study were to examine the relationship between anxiety and systemic inflammation in individuals at risk for cardiovascular disease and to determine if single-nucleotide polymorphisms (SNPs) associated with inflammation moderate this relationship. Methods A secondary analysis was cond...
Conclusions Young adults are not armed with the accurate knowledge to make informed choices about using e-cigarettes. E-cigarette users are understudied and tend to value appearance and physical sensation over health. Social norms related to e-cigarette use are linked to perception of identity and the current technology-focused culture.
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