At the American College of Allergy, Asthma and Immunology’s annual meeting this week, two drug juggernauts showcased promising data on their respective anti-inflammatory blockbusters, bolstering approval ambitions at the FDA.
Specifically, Regeneron recently received a priority review tag from the FDA in its bid to secure Dupixent’s ninth approval, this time in adults and kids ages 6 years and older with allergic fungal rhinosinusitis (AFRS). Regeneron confirmed the status of its application as it reported Friday that a late-stage trial of Dupixent in AFRS met all primary and secondary endpoints.
Presenting at the same conference, AstraZeneca spotlighted strong phase 3 data on the ability of its monoclonal antibody, Fasenra, to delay the time to first worsening or flare in patients with the rare condition hypereosinophilic syndrome (HES), which can lead to progressive organ damage. AZ is currently preparing a regulatory filing in the hopes of eventually securing a Fasenra green light in the indication, according to a Nov. 7 press release.
Breaking down the data, Regeneron’s Sanofi-partnered Dupixent led to significant reductions in sinus opacification, nasal congestion and nasal polyps versus placebo in patients with AFRS.
A chronic type 2 inflammatory disease, AFRS is a subtype of chronic rhinosinusitis caused by intense allergic hypersensitivity to fungi, with aspergillus the most common culprit, Regeneron explained.
The condition, which most often affects people in warm, humid climates where fungal spores are common, can trigger nasal polyps, congestion, loss of smell, bone loss around the sinus cavities and facial deformities, among other symptoms, Regeneron noted. Treatment of AFRS today primarily involves surgery and prolonged courses of steroids.
In Regeneron’s study of 62 adults and kids with AFRS, Dupixent helped improve participants’ sinus opacification scores—a measure of nasal congestion determined by computed tomography scans—by 50%, compared to just 9.8% in the study’s placebo arm. That showing was strong enough to satisfy the trial’s primary endpoint.
Dupixent is already approved in myriad autoimmune and inflammatory conditions, including atopic dermatitis, eosinophilic asthma, chronic rhinosinusitis with nasal polyps and eosinophilic esophagitis.
As for AZ’s data, Fasenra delayed the time to first HES worsening or flare and “significantly reduced” the risk of HES worsening or flare by 65% compared to placebo in the late-stage Natron trial, the British drugmaker said in a Friday press release.
“The Natron results confirm Fasenra’s ability to address eosinophilic inflammation in difficult-to-treat eosinophilic-driven diseases, like HES and eosinophilic granulomatosis with polyangiitis, in addition to severe eosinophilic asthma,” Sharon Barr, EVP of biopharmaceuticals R&D at AstraZeneca, said in a statement.
“By sharing the full results from Natron with the medical community today and progressing our regulatory filing, we hope to realize a future in which Fasenra helps patients with HES who currently have very limited options,” she continued.
Aside from the primary endpoint, AZ’s trial met each of its secondary goals as well. Fewer Fasenra patients (22.4%) experienced a flare or withdrew from the trial versus patients (45.5%) in the control cohort. Fasenra also led to a 66% reduction in the yearly rate of patients’ HES flares versus placebo, AZ added.
AZ plans to present further on the Fasenra data in HES at the annual meeting of the American Society of Hematology next month. One of the trials’ secondary endpoints is on time to first hematologic relapse.
Fasenra currently boasts approvals as both an add-on maintenance treatment for severe eosinophilic asthma and in eosinophilic granulomatosis with polyangiitis. For all of 2024, the drug generated (PDF) global sales of $1.68 billion.