The First FDA-Approved Biologic Drug to Treat Uncontrolled COPD

Dupixent (dupilumab), a drug already used to treat atopic dermatitis and asthma, became the first biologic approved for chronic obstructive pulmonary disease (COPD) last fall.

Most COPD treatments come as inhalers, while Dupixent is an injectable. However, about half of the patients who use three different kinds of inhaled medications continue to experience COPD flare-ups, according to drugmakers Regeneron and Sanofi.

Dupixent offers an option for adults with moderate-to-severe COPD whose disease isn’t under control despite using multiple treatments.

However, the drug is not for all COPD patients. It is only approved for people with high levels of eosinophils, a type of immune cell that contributes to inflammation. Regeneron said about 300,000 COPD patients in the United States are eligible for the medication.

Dupixent targets parts of the immune system that activate eosinophils to help calm down inflammation. This helps treat the root cause of COPD rather than just alleviating the symptoms.

“It had been quite a long time since we really had a treatment that we were excited about in COPD,” said Ashraf Fawzy, MD, MPH, a pulmonary and critical care physician at Johns Hopkins Medicine. “It gives us that extra tool in our tool belt to use for people who are still continuing to have flares and poor symptoms despite the fact that they’re on other medicines.”

How Dupixent Works for COPD

Dupixent is a monoclonal antibody that has been on the market for years. The blockbuster drug is already approved for other inflammatory diseases, such as asthma, atopic dermatitis, and chronic rhinosinusitis.

It works by binding to the receptor of an immune cell called interleukin-4 (IL-4), blocking the effects of both IL-4 and another immune cell, IL-13. These cells help activate eosinophils, so blocking them reduces inflammation in the lungs and throughout the body that can occur in people with high eosinophil counts. Tamping down the IL-13 pathway could also help regulate mucus production in the lungs.

A pair of late-stage clinical trials showed Dupixent was effective in treating COPD. The group that took Dupixent on top of their standard of three inhaled medications were 30% to 34% less likely to experience exacerbations, sometimes called breathing flare-ups, compared to those taking a placebo. The Dupixent group also had better lung function, less intense breathing problems, and higher quality of life over time.

What Are COPD Exacerbations?

Exacerbations are sudden periods of worse COPD symptoms that usually subside within a few days. For many COPD patients, however, an exacerbation can be severe enough to send them to the hospital.

“We believe that the more exacerbations you have, the more rapid your lung function declines,” said M. Bradley Drummond, MD, MHS, professor of medicine and director of the Obstructive Lung Diseases Clinical and Translational Research Center at the University of North Carolina School of Medicine.

“It’s really a marker of disease severity, and so preventing those exacerbations becomes very important in trying to reduce mortality and preserve lung function,” he added.

Medicare data shows that among adults older than 65 who are hospitalized for an exacerbation, one in four will die within the next year.

Importantly, Dupixent is meant to treat people whose COPD cannot be controlled with other therapies. There are three main types of COPD medication, all of which are given through an inhaler. Two open the airways, and one is an inhaled steroid.

“From an inhaled medication standpoint, that’s kind of all we have—there’s nothing else in our toolbox to reach for. So, when we see a 30%-34% reduction in the annual rate of exacerbations on top of what has historically been our maximal inhaled therapies, that gets us really excited,” Drummond said.

How to Know If Dupixent Is Right for You

The first step to knowing if Dupixent makes sense for you, Drummond said, is to pay attention to whether your condition is well controlled.

“You have to recognize exacerbations when they happen,” Drummond said. “If somebody’s having three or four chest colds a year and are going to urgent care, that’s somebody who has uncontrolled disease.”

The next step is to understand if you have type 2 inflammation using a simple blood test. The typical complete blood count panel includes an eosinophil count, so most people already have that information in their medical records.

According to the drugmakers, most of the side effects are mild and go away with time. Those include injection site reactions, common cold symptoms, and upper respiratory tract infections. There’s a slightly higher risk of developing lung infections and heart-related health events on Dupixent, though clinical trials showed a similar heart disease risk in the placebo group.

“Our biggest hurdle is usually insurance coverage,” Fawzy said. “The medications are expensive, and we have to jump through hurdles with doing prior authorizations and keeping up with all the requirements from insurance companies.”

The list price is $3,993 for a one-month supply.

How Is Dupixent Administered?

Dupixent is administered as an injection under the skin every two weeks. Fawzy said that in his experience prescribing Dupixent for asthma, patients tend to have little difficulty administering the drug.

“As medications for obesity and diabetes come to market, it’s become more and more common for people to be using injection medicines, so people aren’t as surprised when I mentioned that it’s an injection medicine,” Fawzy said.

He said the drug has worked so well for COPD and asthma that he’s had no problems with patients being adherent.

Dupixent Could Move the Needle on COPD Treatment

Dupixent isn’t the first biologic tested in people with COPD. There are six biologics approved for asthma and almost all of them have been studied in COPD, Drummond said.

The problem, Drummond said, is that those drugs were tested in a broad sample of COPD patients. But there are many different types of COPD, and treatments that work for some patients will fail for others. Dupixent succeeded because it was tested in a select group of individuals with type 2 inflammation, he explained.

Fawzy said that COPD has been historically difficult to study because it’s not easy to replicate in animal and lab models. As researchers identify the biological pathways relevant to certain groups of COPD patients, they’re getting closer to understanding which biologics work for whom.

“The fact that we have accepted COPD as a systemic disease—essentially a disease that doesn’t just affect the lungs, but can be targeted in different ways—is very important,” Fawzy said.

Most COPD cases involve inflammatory cells called neutrophils rather than eosinophils. Fawzy said he hopes Dupixent’s success will open new avenues for the development of drugs that target neutrophils and can help a broader group of COPD patients.

“I do feel [the Dupixent approval] has started to shift the tide towards more drug development in COPD,” Fawzy said. “It’s a pretty significant disease that causes a lot of morbidity for a sizable portion of patients. There is a lot of potential here to do better for our patients and to better understand the disease and better treat it.”