The field of pulmonology saw several significant developments in September, including new FDA approvals, promising clinical trial results, and insights into treatment strategies for various respiratory conditions.
Dupixent Approved for COPD
Regeneron announced FDA approval of dupilumab (Dupixent) for chronic obstructive pulmonary disease (COPD). The decision was based on positive findings from the BOREAS and NOTUS trial programs. According to George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer at Regeneron, this approval 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," offering a novel option to reduce exacerbations, improve breathing, and enhance quality of life.
Benralizumab Approved for EGPA
Benralizumab received FDA approval for adults with eosinophilic granulomatosis with polyangiitis (EGPA). This approval was supported by phase 3 findings from the MANDARA study, published in the New England Journal of Medicine, which compared benralizumab to mepolizumab (Nucala). Michael Wechsler, MD, MMSc, MANDARA investigator and professor of Medicine and director of The Asthma Institute at National Jewish Health, noted that "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."
Depemokimab Shows Promise in Severe Asthma
New data from late-stage SWIFT-1 and SWIFT-2 studies revealed that depemokimab, an ultra-long-acting biologic for severe asthma, reduced serious asthma attacks by over 50% and exacerbations leading to hospitalization by 72%. The drug is administered twice yearly. Kaivan Khavandi, the GSK global head of Respiratory/Immunology R&D, stated that "depemokimab could offer the possibility of sustained inhibition of this pathway, with a dosing schedule of just two injections per year."
Mirtazapine Ineffective for Breathlessness
Phase 3 findings indicated that mirtazapine, an antidepressant, does not improve breathlessness in individuals with respiratory disease. Irene Higginson, FFPHM, from King’s College London, commented, "Despite being a widespread issue, we still don’t have effective treatments available. As such, many doctors turn to off-label prescribing, trying to help their patients."
Consensus on Alpha-1 Antitrypsin Deficiency
A study compiling opinions from pulmonologists across 15 European countries addressed the assessment and management of severe alpha-1 antitrypsin deficiency (AATD). The goal was to inform a standardized treatment pathway and improve patient outcomes. Marc Miravitlles, MD, PhD, a pulmonologist and senior researcher at the Vall d’Hebron University Hospital, noted, "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."
