FDA Roundup: ATX101 Gains Breakthrough Therapy Designation, Stelara Biosimilar Approval
Catch up on important FDA news from the week of December 2.
Post-Surgical Pain Treatment Gains FDA Breakthrough Therapy Designation
FDA Roundup: ATX101 Gains Breakthrough Therapy Designation, Stelara Biosimilar Approval / Tada Images - stock.adobe.com
The FDA granted Breakthrough Therapy Designation to ATX101 for the treatment of postsurgical pain following total knee arthroplasty in adults. The designation was given to the therapy based on positive data from a recently completed phase 2B exploratory dose-ranging trial, which was concluded early based on efficacy.
ATX101 is a novel investigational configuration of bupivacaine and a biopolymer that has been designed to provide pain relief after orthopedic surgery. The therapy, which has a high density of medication within a small footprint, is placed in at the end of standard surgery to deliver an analgesic effect over weeks before dissolving into water and carbon dioxide. Allay said ATX101 aims to replace the existing mix of analgesic products used for shorter-term pain management.
The phase 2B study showed that ATX101 had a rapid onset of action and efficacy over the first 24 hours that was comparable to bupivacaine. There was a clinically meaningful separation in dose response between the 1500 mg ATX101 group compared to the bupivacaine group through weeks 1, 2 and 3. Patients receiving ATX101 also showed meaningful improvements in key indicators of function through 30 and 60 days.
FDA Approves Stelara Biosimilar Ustekinumab-kfce
The FDA approved ustekinumab-kfce (Yesintek), a biosimilar reference product to Stelara from Johnson and Johnson, Biocon Biologics announced in a release.1 The monoclonal antibody was approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. In February 2024, Biocon entered into a settlement and licensing agreement with Johnson and Johnson to commercialize ustekinumab-kfce in the United States no later than on February 22, 2025, upon FDA approval.
“This agreement for a biosimilar Ustekinumab is an important milestone in our company’s commitment to delivering affordable, life-changing biosimilar medicines,” Matthew Erick, chief commercial officer of advanced markets at Biocon said in a release at the time of the agreement.2 “It underscores the Company’s steadfast resolution of supporting the well-being of patients impacted by inflammatory diseases and driving positive change within the healthcare industry.”
Johnson and Johnson Submits 2 sBLA’s for Guselkumab in Pediatric Patients
Johnson and Johnson has submitted 2 supplemental Biologics License Applications (sBLAs) to the FDA for guselkumab (Tremfya) for the treatment of moderate-to-severe plaque psoriasis in children 6 years of age and older and active juvenile psoriatic arthritis in children 5 years of age and older, the company announced in a release.3
The sBLA for plaque psoriasis was based on data from the phase 3 PROTOSTAR study and the sBLA for juvenile psoriatic arthritis was based on extrapolation analyses from the DISCOVER 1 and 2, as well as efficacy and safety data from the PROTOSTAR study. Guselkumab is the first approved monoclonal antibody that selectively binds to the p19 subunit of IL-23 and is currently approved to treat severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active ulcerative colitis in adult patients.
“This milestone underscores our commitment to transform the standard of care for patients of all ages and builds on our expertise and legacy in IL-23 and immune-mediated diseases,” Liza O’Dowd, MD, vice president at Johnson & Johnson Innovative Medicine, said in a release.3 “There is a critical gap in the treatment of children and adolescents with these skin and joint conditions, where debilitating symptoms can present challenges related to physical appearance and ability to function.”
READ MORE: FDA Updates
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