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Regeneron, Sanofi's Dupixent Get FDA Approval For Chronic Obstructive Pulmonary Disease Treatment

(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNY), Friday announced that the U.S. Food and Drug Administration has approved Dupixent as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease or COPD and an eosinophilic phenotype. Sanofi claimed that Dupixent will be nation's first biologic medicine approved for these conditions.

COPD is a respiratory disease that damages the lungs and causes progressive lung function decline. Its symptoms include persistent cough, excessive mucus production, and shortness of breath.

The approval was based on phase 3 studies that demonstrated reduction in exacerbations, as well as improvements in lung function and health-related quality of life in Dupixent patients compared to placebo.

In July, Dupixent received approval from the European Medicines Agency as an add-on maintenance treatment for adults with uncontrolled COPD characterized by raised blood eosinophils.

Dupixent is awaiting regulatory approvals in several nations across the world, including in Japan, Sanofi noted.

Currently, Regeneron's stock is trading at $1,063.05, up 2.22 percent, and Sanofi's stock is trading at $57.90, up 1.60 percent on the Nasdaq.

FDA Approves Dupilumab As First Biologic Treatment For COPD

The FDA approved dupilumab today as the first biologic treatment for patients with uncontrolled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype to significantly help reduce exacerbations and improve lung function.

The FDA approved dupilumab (Dupixent; Regeneron/Sanofi) today for treating patients with uncontrolled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.1

This approval makes dupilumab the first biologic treatment for COPD. It is a human monoclonal antibody that inhibits the signaling of IL-4 and IL-13 pathways, central drivers of the type 2 inflammation underlying COPD and related conditions, like asthma and atopic dermatitis; it is administered via subcutaneous injection. Dupilumab was previously approved to treat patients with moderate to severe atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis.

The FDA approved dupilumab today as the first biologic treatment for patients with uncontrolled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.Image Credit: cartoon - stock.Adobe.Com

"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 in Phase 3 trials," George D. Yancopoulos, MD, PhD, principal inventor of dupilumab and board cochair, president, and chief scientific officer at Regeneron, said in a statement.

This approval was based on results from the phase 3 BOREAS (NCT03930732) and NOTUS (NCT04456673) trials, which demonstrated that dupilumab can significantly reduce COPD exacerbations.2 The first trial was BOREAS, which evaluated the safety and efficacy of dupilumab in 939 adults aged 40 to 80 with moderate to severe COPD; all participants were current or former smokers.3 

In this trial, dupilumab met the primary end point by reducing moderate or severe acute COPD exacerbations at 52 weeks (P = .0005; 30% reduction). It also demonstrated dupilumab's ability to significantly improve lung function at 12 weeks compared to placebo (P < .0001; 60 mL vs 77 mL, respectively); its benefits lasted up to week 52 (P = .0003).

"BOREAS opened up a completely new understanding of presentations in terms of inflammation of COPD," Klaus Rabe, MD, PhD, one of the study's investigators, said in an interview with The American Journal of Managed Care® at the European Respiratory Society Congress.4 "...Since it [type 2 inflammation] does play a role, it's amenable to change with something that addresses type 2 inflammation through, for example, a monoclonal antibody, something like Dupixent."

Next, the NOTUS trial, a replicate trial to BOREAS, evaluated the efficacy and safety of dupilumab for 935 patients aged 40 to 85 years with uncontrollable COPD and type 2 inflammation taking the maximal standard-of-care inhaled therapy (triple therapy)5; like the BOREAS trial, these patients were current or former smokers.

It met its primary end point, confirming the results of the BOREAS trial and demonstrating that dupilumab significantly reduced COPD exacerbations by 34% compared to the placebo arm. However, 67% of those in the experimental arm and 66% of the placebo arm had adverse events (AEs); the most common AEs were diarrhea, back pain, and headache.2

The European Medicines Agency approved dupilumab as an add-on treatment for patients with COPD in July 2024,1 and it was also approved earlier today in China.6

"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," Jean Wright, MD, chief executive officer of the COPD Foundation, said.1 "...We welcome the approval of this new therapeutic option to offer patients a new way to help gain better control of their disease."

References

Dupixent approved in the US as the first-ever biologic medicine for patients with COPD. September 27, 2024. Accessed September 27, 2024. Https://www.Globenewswire.Com/en/news-release/2024/09/27/2954551/0/en/Press-Release-Dupixent-approved-in-the-US-as-the-first-ever-biologic-medicine-for-patients-with-COPD.Html

Hunter E. Data from phase 3 trials demonstrate efficacy of dupilumab for treating COPD, type 2 inflammation. December 4, 2023. Accessed September 26, 2023. Https://www.Ajmc.Com/view/data-from-phase-3-trials-demonstrate-efficacy-of-dupilumab-for-treating-copd-type-2-inflammation

Dupixent (dupilumab) late-breaking phase 3 COPD results presented at ATS and simultaneously published in the New England Journal of Medicine. May 21, 2023. Accessed September 26, 2024. Https://www.Sanofi.Com/en/media-room/press-releases/2023/2023-05-21-18-17-12-2672904

Steinzor P. BOREAS trial: new findings on type 2 inflammation in COPD. September 10, 2024. Accessed September 26, 2024. Https://www.Ajmc.Com/view/boreas-trial-new-findings-on-type-2-inflammation-in-copd

Dupixent significantly reduced COPD exacerbations in second positive phase 3 trial, accelerating FDA submission and confirming potential to become first approved biologic for this serious disease. Sanofi. November 27, 2023. Accessed September 26, 2024. Https://www.Sanofi.Com/en/media-room/press-releases/2023/2023-11-27-06-30-00-2785836

Dupixent approved in China as the first-ever biologic medicine for patients with chronic obstructive pulmonary disease (COPD). September 27, 2024. Accessed September 27, 2024. Https://www.Globenewswire.Com/news-release/2024/09/27/2954417/0/en/Dupixent-dupilumab-Approved-in-China-as-the-First-ever-Biologic-Medicine-for-Patients-with-Chronic-Obstructive-Pulmonary-Disease-COPD.Html

Voice Changes Recorded On A Smartphone Can Indicate Flare Up Of COPD Symptoms, Reports Research

Changes in people's voices recoded on a smartphone can signal a serious flare up in symptoms of chronic obstructive pulmonary disease (COPD), according to a pilot study presented at the European Respiratory Society (ERS) Congress in Vienna, Austria.

COPD, which includes emphysema and chronic bronchitis, is a serious and long-term lung condition. According to the World Health Organisation, COPD is the third leading cause of death worldwide.

A flare-up in symptoms, such as difficulty breathing and coughing, is known as an exacerbation. During an exacerbation patients may need extra treatment or hospitalisation, and their risk of dying increases. However, if treatment can be given at a very early stage, these risks are far lower.

The study was presented by Ms Loes van Bemmel, a researcher in the department of respiratory medicine at Maastricht University Medical Centre in the Netherlands. She said: "After an exacerbation, patients report a lower quality of life, their lung function can decline, and patients are at an increased and prolonged risk for cardiovascular events such as heart attack and stroke. It's vital to detect exacerbations as early as possible so appropriate treatment can be given. Unfortunately, it has proved difficult to detect exacerbations at their onset, since symptoms usually start when patients are at home.

"Patients and their families have told us that there are voice changes before and during exacerbations. We wanted to see if we could record patients' speech at home and analyse these recordings for early signs of an exacerbation."

Twenty-eight people with COPD took part in the research. Researchers asked them to record their voices via a smartphone app every day for 12 weeks. They recorded themselves saying "aah" for as long as they could manage with one breath, then either reading a short paragraph of a story or answering a question.

Participants also completed a daily questionnaire to gauge their COPD symptoms. During the study, there were 16 occasions when a patient experienced a flare-up of symptoms.

Researchers analysed the voice recordings and looked for changes that coincided with symptom flare-ups. They found that patients' voices became higher pitched when an exacerbation was imminent. They also found more 'jitter' in patients voices when an exacerbation was beginning. Jitter is when a voice sounds breathy or hoarse.

Ms van Bemmel said: "There were clear differences between patients' recordings on a normal day and on the first day of an exacerbation. This confirmed our hypothesis that speech changes significantly, even at the very beginning of an exacerbation.

"These are preliminary results, so our findings need to be validated in larger numbers of patients with COPD. If we are able to do this, it would pave the way for early detection and diagnosis of exacerbations in the home environment. This would enable patients to manage these events themselves at home.

"While every disease is different, speech analysis could potentially help in other respiratory diseases as well. We suspect there are speech biomarkers for many respiratory diseases."

Ms van Bemmel and her colleagues are now planning research to build on their findings. In partnership with researchers at Radboud University Medical Centre in the Netherlands, the team will co-create a mobile app with people living with COPD. The SPEAK app will be used by patients to detect exacerbations via speech signals and give support for treating symptoms in the home. At the same time, the researchers are looking into ways to responsibly collect, store and analyse speech data so that the privacy of the speaker is maintained.

Professor Frits Franssen is Secretary of the ERS assembly on respiratory clinical care and physiology, Head of the Department of Respiratory Medicine at Maastricht University Medical Centre, Netherlands, and was not involved in the research. He says: "COPD is a common and serious condition. When symptoms flare up, it can lead to a long-term deterioration in health and can even be fatal. If we spot these exacerbations early and give treatment, we know that serious complications can often be averted. At the moment, that means the patient or their family deciding something is wrong then seeing a doctor for assessment and tests.

"This research is interesting because it suggests that the early signs of a COPD exacerbation can be picked up via changes in a patient's voice recorded on a smartphone. This finding needs to be tested in a larger study. If it can be validated, this could lead to a quick and efficient system to alert a patient and their doctor that treatment is needed. Because it works via a smartphone, voice analysis could be used by anyone, at anytime and anywhere. This could ultimately save money, time and patients' lives."`

Reference:

Voice changes recorded on a smartphone can indicate a flare up of COPD symptoms, European Respiratory Society, Meeting:European Respiratory Society Congress 2024.

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