Pulmonology Month in Review: September 2024

In the month of September, several notable news stories in the field of pulmonary health were covered by the team at HCPLive. The pulmonology field saw a variety of advancements in September, including 2 US Food and Drug Administration (FDA) approvals and the introduction of the Respiratory Report series.

The review also covers new findings on treatment options for asthma and breathlessness. The following highlights of the team’s coverage represent a broad overview of the month of September’s most significant pulmonology-related stories:

FDA News and Updates:

FDA Approves Dupilumab (Dupixent) for Treatment of COPD

A September announcement by Regeneron highlighted the approval of dupilumab (Dupixent) treatment for patients with chronic obstructive pulmonary disease (COPD). The approval decision by FDA officials followed positive findings from the BOREAS and NOTUS trial programs.

“This latest FDA approval for (dupilumab) represents new hope for the hundreds of thousands of COPD patients in the U.S. who can sometimes struggle just to breathe during their everyday lives,” George D. Yancopoulos, MD, PhD, the president and chief scientific officer at Regeneron, and principal inventor of dupilumab, said in a statement. “...This latest approval represents an important next chapter for (dupilumab), giving those with COPD a novel option that has demonstrated the unprecedented ability to help patients experience fewer exacerbations, while also helping them breathe better and improve quality of life in Phase 3 trials.”

FDA Approves Benralizumab for Eosinophilic Granulomatosis with Polyangiitis

Another FDA approval announced in September was that of benralizumab for adults with eosinophilic granulomatosis with polyangiitis (EGPA). This decision by the agency was based upon the phase 3 findings of the MANDARA study published in the New England Journal of Medicine.

This research had compared benralizumab to the only FDA-approved medication available for EGPA at the time, which was mepolizumab (Nucala). It was also described by AstraZeneca as the first head-to-head non-inferiority study of biologics among those with EGPA.

“Patients often rely on long-term oral corticosteroids, which can cause serious and lasting side effects,” Michael Wechsler, MD, MMSc, MANDARA investigator and professor of Medicine and director of The Asthma Institute at National Jewish Health, said in a statement. “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.”

New Series Announcement:

Welcome to The Respiratory Report

In another September article, the new quarterly newsletter from HCPLive known as The Respiratory Report was introduced. The series features updates from pulmonary investigators who are supported by the American Lung Association Research Institute, with each issue available at HCPLive.com as well as through the email newsletter list.

The Respiratory Report provides an introduction to the development of practice-changing research described by the investigators leading the research. Each iteration of the series includes video interviews and written articles describing a wide array of topics, such as asthma, COPD, rare interstitial diseases, and respiratory viruses. It is also described as similar to the HCPLive series Lungcast.

Other News in Pulmonology:

Positive Phase 3 Findings Identified for Depemokimab Treatment of Severe Asthma

Depemokimab, a drug formulated as an ultra-long-acting biologic option for patients with severe asthma, was shown in a new study to reduce serious asthma attacks by over 50%. The study also found a 72% reduction of exacerbations resulting in hospitalization. The drug is administered to patients 2 times per year at intervals of 6 months. These new data were the conclusion of the late-stage SWIFT-1 and SWIFT-2 studies.

“These results add to the established body of evidence that targeted inhibition of IL-5 plays a key role in reducing type 2 inflammation that drives severe asthma exacerbations,” Kaivan Khavandi, the GSK global head of Respiratory/Immunology R&D, said in a statement. “Depemokimab could offer the possibility of sustained inhibition of this pathway, with a dosing schedule of just two injections per year.”

Mirtazapine Fails to Ease Breathlessness in New Study Despite Previous Hopes

New phase 3 findings on mirtazapine suggest that the antidepressant does not improve breathlessness among individuals with respiratory disease. Previously, it had been suggested that antidepressants could modulate respiratory sensation even without a mood disorder, as it raises levels of serotonin in respiratory control and other regions.

“Despite being a widespread issue, we still don’t have effective treatments available,” first author Irene Higginson, FFPHM, from King’s College London, said in a statement. “As such, many doctors turn to off-label prescribing, trying to help their patients.”

Survey Provides Updated Expert Opinions on Severe AATD Assessment, Monitoring

Another study covered in September was a compilation of opinions from pulmonologists from across 15 different European countries related to the assessment and management of severe alpha-1 antitrypsin deficiency (AATD). The investigators sought to inform a standardized treatment pathway and to help improve outcomes seen among patients.

“Discordance currently exists among published guidelines for the assessment and management of patients with severe AATD,” Marc Miravitlles, MD, PhD, ​​a pulmonologist and senior researcher at the Vall d’Hebron University Hospital and the Vall d’Hebron Research Institute in Spain, and colleagues wrote. “To our knowledge, this is the first study that attempts to establish a consensus for the treatment and monitoring of patients with AATD using Delphi consensus methodology.”