FDA approves Dupixent for adults with poorly controlled COPD
Approval as add-on maintenance treatment is sixth for biologic in US
The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with poorly controlled chronic obstructive pulmonary disease (COPD) and high counts of immune cells called eosinophils.
Elevated eosinophils are a marker of type 2 inflammation, which is thought to contribute to COPD-related lung inflammation.
The approval comes after the FDA delayed its decision by three months to give regulators enough time to complete their review. With it, the therapy from Sanofi and Regeneron becomes the first biologic available in the U.S. to treat COPD. A biologic is a type of medication that comes from a living organism or its products.
“With today’s approval, Dupixent once again paves the way and becomes the first and only approved add-on biologic medicine for inadequately controlled COPD, giving patients living with this devastating disease the chance to look forward to the potential of improved breathing and a life with fewer exacerbations,” Paul Hudson, Sanofi’s CEO, said in a company press release.
In the U.S., the expansion of Dupixent’s label to include COPD brings the number of approved indications up to six, adding to its use as a treatment for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis — all driven in part by type 2 inflammation.
“Dupixent has already shown it can revolutionize the treatment paradigm of many diseases driven in part by type 2 inflammation with high unmet medical needs, with one million patients being treated globally across all currently approved indications,” Hudson said.
Simultaneously, the therapy was also approved for the same indication in China. Dupixent also had been cleared for use in COPD in the European Union in early July, also for patients with uncontrolled disease. Similar applications are also under review in other regions, including Japan, Sanofi noted.
Dupixent approval for COPD ‘represents new hope’ for patients
Regeneron also is pleased by Dupixent’s approval for this new indication, according to George D. Yancopoulos, MD, PhD, board co-chair, president, and chief scientific officer of the company, who said it “represents new hope for the hundreds of thousands of COPD patients in the US” for improving their daily lives.
“This latest approval represents an important next chapter for Dupixent, 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,” Yancopoulos said.
COPD is an inflammatory disease that restricts airflow from the lungs, causing difficulty breathing. Standard treatment for COPD includes inhaled corticosteroids and bronchodilators, which ease inflammation and relax and widen the airways to help with breathing.
However, many patients still experience frequent flare-ups or exacerbations, where symptoms worsen suddenly. For those with an eosinophilic profile, marked by high blood eosinophils, flare-ups are particularly severe.
Dupixent is an antibody that specifically blocks the IL-4 receptor alpha, which is involved in the signaling of both IL-4 and IL-13, two chemical messengers crucial for type 2 inflammation. As such, Dupixent is expected to ease inflammation and reduce the number of flare-ups, while helping with breathing.
“People living with inadequately controlled COPD have long awaited new medicines to help manage the daily suffering they experience from breathlessness, coughing, wheezing, exhaustion and unpredictable hospitalization,” said Jean Wright, MD, the CEO of the COPD Foundation. “These patients often struggle with everyday activities many people take for granted such as taking a walk or running errands outside the home.”
This latest approval represents an important next chapter for Dupixent, 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.
The approval drew on positive data from BOREAS (NCT03930732) and NOTUS (NCT04456673), two Sanofi-sponsored Phase 3 clinical trials involving more than 1,800 adults with moderate to severe COPD and signs of type 2 inflammation.
The participants, who were on maximal standard-of-care inhaled therapy, were randomly assigned to receive either Dupixent or a placebo. These were given every other week as a subcutaneous, or under-the-skin, injection, in addition to their standard treatment.
Compared with the placebo, Dupixent significantly reduced the number of flare-ups by up to 34% in a year, and improved lung health and life quality.
The overall safety profile of Dupixent in these studies was consistent with its use in other indications. According to its label, the therapy’s most common side effects in people with COPD include viral infections, headaches, common cold, back pain, diarrhea, joint pain, urinary tract infection, injection-site reactions, rhinitis — which includes nasal congestion, runny nose, sneezing, and itching — high eosinophil counts, toothache, and inflammation of the stomach’s lining.
“We welcome the approval of this new therapeutic option to offer patients a new way to help gain better control of their disease,” Wright said.
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