Dupixent for COPD: FDA Approves First-Ever Biologic for This Common Respiratory Condition

Many of today's chronic obstructive pulmonary disease (COPD) treatments improve your ability to breathe, exercise, and go about your daily life. COPD, though, is a complex condition and there's a chance your body may benefit from another medication. Perhaps you're experiencing persistent flare-ups, or maybe your symptoms are still more intense than you can tolerate.

This is where a biologic for COPD could make a difference. Biologics are prescription medications that can target specific parts of the immune system to calm down inflammation. This means they can treat a root cause of COPD rather than just alleviating symptoms.

If you have moderate-to-severe COPD and need another source of relief, your prescriber may recommend Dupixent (dupilumab). It's an injectable biologic that is now FDA approved to treat certain adults with inadequately controlled COPD and an eosinophilic phenotype (a high level of blood eosinophils). It's the first medication of its kind, and you can conveniently administer your doses at home.

Here, we'll cover what you should know about receiving Dupixent for COPD.

Dupixent for COPD: Why its approval matters

Dupixent is the first biologic medication for COPD. The FDA approved it for this use in September 2024. The approval represents a promising step forward for people living with COPD that would benefit from an additional medication. Dupixent can help adults with COPD avoid exacerbations (symptom worsening) and enjoy better lung function, among other effects.

Dupixent's approval for COPD is also intriguing from a scientific lens. Biologics can help treat different health conditions in a more targeted way. But getting a COPD biologic approved has been several years in the making. There haven't been any new types of COPD medications approved in over 10 years, either.

Why the delay? Many biologics for COPD haven't worked well in clinical trials. COPD is a complex health condition involving multiple mechanisms that contribute to lung damage and inflammation. People tend to have varying responses to these treatments.

What else is Dupixent used for?

COPD is one of Dupixent's many uses. Dupixent is now approved to treat six different health conditions.

In addition to COPD in adults, Dupixent can treat:

• Moderate-to-severe atopic dermatitis (eczema) in adults and kids ages 6 months and older who don't respond to or can't use topical treatments

• Eosinophilic esophagitis (allergic inflammation in the esophagus) in adults and kids ages 1 year and older

• Moderate-to-severe asthma in certain adults and kids ages 6 years and older

• Chronic rhinosinusitis (sinus inflammation) with nasal polyps in adults and adolescents ages 12 and older

• Prurigo nodularis (a bumpy skin condition) in adults

How does Dupixent work for COPD?

Dupixent is a monoclonal antibody that's injected under the skin once every 2 weeks for COPD. A monoclonal antibody is a lab-made protein that's designed to target specific substances in your body.

Dupixent's target is the interleukin-4 (IL-4) receptor (binding site). It's part of the immune system. By blocking this receptor, Dupixent interferes with the signaling of two different inflammatory proteins: IL-4 and interleukin-13 (IL-13).

Like a dam in a river, this causes several downstream effects. Blocking IL-4 and IL-13 prevents several inflammatory responses - such as eosinophil activation and mucus production - from causing swelling in the lungs. This is thought to lead to better lung function and easier breathing.

This COPD biologic won't be able to help everyone with the condition, though. It's most effective for adults with COPD that have type 2 inflammation. This is a form of inflammation that involves certain immune cells in your body. IL-4 and IL-13 are both culprits behind type 2 inflammation.

Less than half of people with COPD have this form of inflammation. Your prescriber will likely collect your bloodwork to determine if you'll benefit from the medication or not.

How effective is Dupixent for COPD?

The bulk of what we know about Dupixent's effectiveness for COPD comes from two clinical trials. They're phase 3 studies named BOREAS and NOTUS. These are the studies that provided the evidence for Dupixent's approval for COPD.

In the first study (BOREAS), Dupixent was compared to placebo - an injection with no medication in it. Over a 1-year period, people receiving Dupixent experienced a 30% reduction in moderate or severe COPD exacerbations compared to placebo. They also experienced better lung function over time, less intense breathing problems, and a higher quality of life. Some of these effects were noticeable after just a few weeks.

Dupixent was similarly effective in the second study (NOTUS). And as Dupixent starts to be used outside of clinical trials for COPD, we'll continue to learn more about its real-world effectiveness.

David Mannino, MD, cofounder and chief medical officer of the COPD Foundation, offered additional context to GoodRx Health on when Dupixent may be beneficial for COPD.

"[Dupixent] will be limited to patients who meet specific criteria based on the FDA approved label for this therapy. For patients who qualify, this has the potential to decrease exacerbations and symptoms," said Mannino. "We have seen in other disease states (such as asthma) dramatic improvements in a subset of patients and are confident that we will see similar improvements in some of our COPD patients."

Good to know: Everyone who participated in Dupixent's clinical trials had moderate-to-severe COPD with type 2 inflammation. They weren't using Dupixent or placebo by themselves, either. In general, everyone received three inhaled maintenance COPD medications at the same time.

What are the side effects of Dupixent for COPD?

Most of Dupixent's side effects are mild. They should go away with time. But, in rare cases, they can be more serious. These side effects may prompt your healthcare team to stop or pause your Dupixent prescription.

Relatively common side effects reported during Dupixent COPD trials include:

• Injection site reactions

• Common cold symptoms

• Upper respiratory tract infections

• Urinary tract infections

• Headache

• Diarrhea

• Back pain

• Joint pain

• Tooth pain

• Nasal inflammation

People living with COPD also have a higher risk of developing lung infections and heart-related health events. Both of these problems were reported in Dupixent's clinical trials, but they occurred in both placebo and Dupixent groups. However, a higher percentage of people in the placebo group experienced heart-related events.

If you're experiencing any bothersome symptoms that you think may be related to Dupixent, reach out to your COPD specialist right away.

How does Dupixent compare to other COPD medications?

Most medications that treat COPD are inhalers. These inhalers may contain one, two, or three different medications that you breathe into your lungs. Tens of stand-alone and combination inhalers are available to consider using.

Five types of inhaled medications can treat COPD:

• Short-acting beta agonists, such as albuterol (Ventolin)

• Short-acting muscarinic antagonists, such as ipratropium (Atrovent)

• Long-acting beta agonists, such as salmeterol (Serevent)

• Long-acting muscarinic antagonists, such as tiotropium (Spiriva)

• Inhaled corticosteroids, such as fluticasone (Flovent)

Between these, there are countless inhaler combinations that your COPD specialist may recommend. But they'll likely want you to inhale one to three long-acting medications every day to keep your symptoms in check - especially if they're frequent or severe. They'll likely recommend having at least one short-acting inhaler on hand to quickly treat breathing exacerbations as needed, too.

Dupixent works differently from these inhalers. It's also administered into your body in a distinct way, and it's given less frequently. It's not meant to replace your COPD inhalers, either. Dupixent is an additional treatment that you can use if your inhalers aren't managing your symptoms sufficiently on their own.

Good to know: Oral medications are also sometimes prescribed for COPD. Medications such as roflumilast (Daliresp) and azithromycin (Azithromycin) may be prescribed to manage flare ups. Dupixent may be used alongside these treatments.

How to save on Dupixent

You'll likely receive Dupixent from a specialty pharmacy if you administer your medication at home. Your specialty pharmacy care team should work with your insurance company to confirm coverage.

There are also other ways to save on Dupixent. GoodRx can help you navigate between copay savings cards and patient assistance programs to save money on your prescription.

• Save with a copay savings card. If you have commercial insurance, you may be eligible to pay as little as $0 per fill for Dupixent using a savings card from the manufacturer.

• Save with patient assistance programs. If you're uninsured or underinsured, you may be eligible for Dupixent's patient assistance program, which offers the medication free of charge.

Frequently asked questions