Allergy Month in Review: September 2024

In the following Month in Review for September 2024, the HCPLive editorial team highlights a variety of stories in the allergy space that were significant or notable during the month of September.

The news reviewed here is meant to provide a set of highlights of September’s coverage of allergy advancements and updates, including stories related to US Food and Drug Administration (FDA) news. The following news represents some of the more significant developments:

FDA News Updates:

FDA Approves Dupilumab for Adolescents with Chronic Rhinosinusitis with Nasal Polyps

One major story covered in September was the approval of dupilumab (Dupixent) as an add-on maintenance therapy for patients in the age range of 12 - 17 years with chronic rhinosinusitis with nasal polyposis (CRSwNP). The treatment, a fully human monoclonal antibody designed to inhibit signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, thus became expanded in terms of its age range, following the June 2019 approval for CRSwNP among individuals aged 18 and older.

“We are pleased to bring the well-established efficacy and safety of Dupixent to the many children suffering from chronic rhinosinusitis with nasal polyps…” George D. Yancopoulos, MD, PhD, Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal dupilumab inventor, said in a statement. “More than one million patients around the world are now being treated with Dupixent, from infants to adults, and across multiple diseases exacerbated by type 2 inflammation, from asthma to atopic dermatitis.”

FDA Approves Benralizumab for Eosinophilic Granulomatosis with Polyangiitis

An approval was also announced in September for benralizumab, specifically for the treatment of adult individuals known to have eosinophilic granulomatosis with polyangiitis (EGPA). The approval was announced by AstraZeneca and based upon findings from the phase 3 MANDARA trial.

“This approval is great news for patients with EGPA in the US who continue to suffer from debilitating symptoms,” MANDARA investigator Michael Wechsler, MD, MMSc, professor of Medicine and director of The Asthma Institute at National Jewish Health, said in a statement. “Patients often rely on long-term oral corticosteroids, which can cause serious and lasting side effects. Benralizumab is a much-needed treatment option, with data showing that not only is remission an achievable goal for EGPA patients, but benralizumab can also help patients taper off steroid therapy.”

Anaphylaxis News:

Neffy Epinephrine Spray Now Available for Preorder

In this update, it was noted that ARS Pharmaceuticals launched its services for preordering the ‘neffy’ epinephrine nasal spray that had been recently approved by the FDA for severe allergic reactions to allergies. The spray represented the first non-injectable epinephrine treatment. This announcement may allow for quick access among patients.

“People with severe allergies have been waiting for a needle-free epinephrine option, which is why we have prioritized a number of support programs, including the launch of today’s pre-ordering service,” Richard Lowenthal, cofounder, President and CEO of ARS Pharmaceuticals said in a statement. “Now, patients can work with their healthcare provider or have a virtual consultation with a physician to obtain a prescription for neffy and get it shipped directly to their homes in as little as 2 days following availability in the US.”

Epinephrine Nasal Spray Now Available as Only Non-Injectable Treatment of Anaphylaxis

In this announcement following the previous one regarding pre-orders, ARS Pharmaceuticals, Inc., declared that the epinephrine nasal spray was officially available nationwide by prescription following the FDA’s July approval. Specifically, 2 mg of the spray was now available for those with Type I allergic reactions such as anaphylaxis.

The medication is considered the first and only syringe-free alternative to injections with epinephrine like the EpiPen. It was notably approved for both adults and children with such allergic conditions who weigh 30 kg or more.

“The introduction of neffy as the first and only needle-free treatment option for patients and caregivers living with severe allergic reactions marks a turning point for ARS Pharmaceuticals and the severe allergy community,” Eric Karas, chief commercial officer of ARS Pharmaceuticals, said in a statement. “Since approval, we have been partnering with healthcare providers, payers, and patient advocates to ensure access for patients.”

Other News:

Omalizumab Improves Outcomes for Patients with Asthma, Comorbid Food Allergy

One study covered in September found that omalizumab (Xolair) treatment resulted in consistent improvements among patients with asthma and comorbid food allergy, though investigators noted that food allergy-specific outcomes remained somewhat unclear.

These data resulted from new research led by Alessandro Fiocchi, MD, director of allergy at the Pediatric Hospital Bambino Gesù in Rome, who conducted a post-hoc analysis of placebo-controlled, randomized clinical studies in addition to real-world observational research.

“The objective of this analysis was two-fold: 1) to assess the effect of comorbid food allergy on the baseline characteristics of patients with asthma, and 2) to assess whether omalizumab could improve healthcare resource use, quality of life, and productivity for patients with food allergy and asthma,” Fiocchi and colleagues wrote.