The newest FDA-approved treatments for COPD are dupilumab (Dupixent), a biologic injection approved in September 2024, and ensifentrine (Ohtuvayre), a first-in-class inhaled medication approved in June 2024. Both represent genuinely new approaches rather than incremental improvements on existing drug classes, and they target different types of patients. Here’s what each one does and who they’re for.
Dupilumab: The First Biologic for COPD
Dupilumab became the first biologic therapy ever approved for COPD when the FDA cleared it in September 2024. It was already widely used for asthma and eczema, but its approval for COPD marked a turning point: it means a subset of COPD patients now have a treatment that targets the underlying immune dysfunction driving their disease, not just the symptoms.
The drug works by blocking two inflammatory signaling molecules that drive a specific pattern of immune overactivity. In COPD, some patients have elevated levels of eosinophils, a type of white blood cell that fuels airway inflammation. Dupilumab is approved specifically for adults whose COPD isn’t controlled by their current medications and whose disease is driven by this eosinophilic inflammation. Regeneron and Sanofi, the companies behind the drug, estimate about 300,000 people in the U.S. fit this profile.
What the Clinical Trials Showed
Two large trials, BOREAS and NOTUS, tested dupilumab against placebo in patients already on standard COPD medications. In the BOREAS trial, published in the New England Journal of Medicine, patients on dupilumab had a 30% lower rate of moderate or severe flare-ups compared to placebo. Their lung function also improved meaningfully: an 83-milliliter greater increase in the amount of air they could forcefully exhale in one second, sustained over a full year. That may sound modest as a raw number, but for people with severely compromised lungs, it translates to noticeably easier breathing.
Who Qualifies
Not every COPD patient is a candidate. You need a blood test showing elevated eosinophil levels. Research on similar biologics suggests the clearest benefit appears at eosinophil counts of 220 cells per microliter or higher, particularly in patients who’ve had multiple flare-ups in the past year despite being on other treatments. Your doctor will check this with a routine blood draw. Dupilumab is given as a self-administered injection, typically every two weeks.
Ensifentrine: A New Class of Inhaled Therapy
Ensifentrine (brand name Ohtuvayre), approved by the FDA in June 2024, is the first inhaled medication in a completely new drug class for COPD in more than two decades. Existing inhalers either relax airway muscles (bronchodilators) or reduce inflammation (corticosteroids). Ensifentrine does both at once through a single mechanism: it blocks two enzymes called PDE3 and PDE4. Inhibiting these enzymes raises levels of chemical messengers inside cells that simultaneously relax airway smooth muscle and dial down inflammatory activity.
You take ensifentrine twice daily, morning and evening, using a standard jet nebulizer with a mouthpiece. Each dose is a 3-milligram liquid ampule that you inhale as a mist. It’s designed to be added on top of your existing maintenance inhalers, not to replace them. Because it works through a different pathway than current bronchodilators, it provides additional airway opening beyond what your other medications already achieve.
Triple Therapy’s Growing Evidence
While not brand new, the evidence for triple therapy (combining three drug types in a single inhaler) has strengthened considerably. A meta-analysis of 13 randomized controlled trials found that triple therapy reduced all-cause mortality by 24% compared to dual bronchodilator therapy alone. That’s a survival benefit, not just symptom relief, which is rare for any COPD treatment.
Triple therapy combines a long-acting muscarinic antagonist, a long-acting beta-agonist, and an inhaled corticosteroid into one device. For many patients with frequent flare-ups, this has become the standard of care before considering newer options like biologics. If you’re currently on two medications and still experiencing exacerbations, stepping up to triple therapy is typically the next move.
Endobronchial Valves for Severe Emphysema
For patients with severe emphysema (a form of COPD where the air sacs are destroyed and hyperinflated), tiny one-way valves placed inside the airways have become an established alternative to lung volume reduction surgery. These endobronchial valves block air from entering the most damaged lobe of the lung, causing it to deflate. This gives the healthier portions of lung more room to expand.
The results from multiple trials are striking. Treated patients saw their lung function improve by 17% to 29% more than control groups, and the targeted lobe shrank by roughly 1,000 to 1,400 milliliters. In one case example, a patient experienced a 41% improvement in lung function after the treated lobe fully collapsed. The procedure is done through a bronchoscope (a thin tube passed through the mouth into the airways) with no surgical incisions, and patients typically go home within a few days.
Not everyone qualifies. You need severe airflow obstruction, significant air trapping, and critically, the fissures separating your lung lobes must be intact. If air can leak between lobes through incomplete fissures, the valve won’t create the pressure difference needed for deflation. Specialized CT scan analysis determines this before the procedure.
Smart Inhalers and Adherence Technology
A less flashy but practically important development is the spread of connected “smart” inhalers that track when and how you use your medication. COPD adherence is notoriously poor. One study using smart inhaler monitoring found that while 59% of prescribed doses were technically taken, only 47% were taken within the correct time window, and just 6% of post-hospitalization COPD patients maintained greater than 80% true adherence to their regimen.
Smart inhalers with audio-visual reminders and feedback from a healthcare provider consistently improve these numbers. In one trial, patients receiving reminders maintained 84% adherence over six months compared to 30% in the control group. Another found that smart inhaler feedback outperformed intensive education sessions, with 73% of doses taken correctly versus 63%. For many people with COPD, better use of existing medications may deliver more benefit than adding a new one.
What’s Still in the Pipeline
Itepekimab, an antibody that blocks a different inflammatory signal called IL-33, is currently in two phase 3 trials (AERIFY-1 and AERIFY-2) expected to report results by late 2025. Unlike dupilumab, which targets eosinophilic inflammation, itepekimab works on an “alarmin” molecule involved in both type 1 and type 2 inflammation. A phase 2 study showed it reduced exacerbations and improved lung function in former smokers with COPD. If the phase 3 results hold up, it could extend biologic therapy to a broader group of COPD patients beyond those with high eosinophil counts.