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Sanofi leans on COPD as 'next major growth pillar' for its immunology star Dupixent: CEO

2024-04-25

临床3期上市批准临床结果

In November, Sanofi and Regeneron’s Dupixent triumphed in a second phase 3 study in COPD, potentially teeing up Dupixent’s approval as the inaugural biologic to treat the lung disease and the first major advancement in the indication in more than a decade.

Even as new SSanofidrugsRegeneronforDupixentAltuviiio come into their own, the FrencCOPDarma’s immunology powerhDupixentixent shows no signs of slowing down. In fact, Sanolung diseasey gearing up for the antibody’s potential debut in what CEO Paul Hudson dubbed the drug’s “next major growth pillar.”

Sanofi is prSanofig to launch Beyfortusin chAltuviiiotructive pulmonary disease (COPD) “as early as late June,” HudsoDupixentn an analyst call Thursday. The FDA is setSanofile on Dupixent’s merits in COPD on June 27. The approval would mark Dupixent’s sixth U.S. indication behind those for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis and prurigo nodularis.

Sanofint already has a strong Dupixenton wchronic obstructive pulmonary disease (COPD)ma and rhinosinusitis nods, Hudson noted. Still, the CEO caveated that FDAwould take some timDupixentve awareness COPDdiagnosis of COPD with type 2 inflammDupixentnd, as a result, the “inflection of sales atopic dermatitisenasthmaOPchronic rhinosinusitisn 2025nasal polyps eosinophilic esophagitis prurigo nodularis

Dupixenthe approval come through, Hudson said he was confident that “COPD will becasthmae nexrhinosinusitis pillar for Dupixent.”COPD type 2 inflammation Dupixent COPD

Back in November, Sanofi and Regeneron’s Dupixent triumphed in a secoCOPDhase 3 study in COPD, potentially teeing up DuDupixent approval as the inaugural biologic to treat the lung disease and the first major advancement in the indication in more than a decade.

Results from the NSanofitudy Regeneronat Dupixent on Dupixent, compared to those on placeCOPDexperienced a 34% reductDupixentOPD exacerbations that needed additional treatment.lung diseasey also produced significant lung function improvement within 12 weeks, which remained intact through 52 weeks.

Meanwhile, Sanofi is also developing another antibodyDupixent COPD—itepekimab—and together with Dupixent, the two COPD drugsCOPDld clinch combined peak sales of roughly 5 billion euros in that indication, Hudson pointed out.

Hudson madeSanofiemarks on Dupixent’s potential COPD launch asCOPD itepekimabsales 25% to 2.8 biDupixentros (arounCOPD billion) in 2024’s first quarter. That performance has cemented Sanofi’s thesis that Dupixent could reach roughly 13 billion euros ($13.9 billion) in sales for the entire year, Hudson said.

Aside from the potential CODupixentDupixent has COPDfited from label expansions in markets beyond the U.S. as well, the CEO pointed out.Sanofi Dupixent

In February, for instanceCOPDpan beDupixent first country to sign off on Sanofi’s anti-inflammatory blockbuster in chronic spontaneous urticaria (CSU), which causes sudden hives, deep swelling under the skin and persistent itch. There are approximately 110,000 people in Japan who suffer from uncontrolled moderate-to-severe CSU, Sanofi noted at the time.

And in the U.S., Dupixent in late January expanded its label in eosinophiSanofiophagitis to include kids between thchronic spontaneous urticaria (CSU)st 33 pounds. The company’s original approval in that indicatipersistent itchof 2022 and included patients ages 12 and up.CSU Sanofi

According to HudsDupixente are now more than 850,000 patients oneosinophilic esophagitish strong sales contributions coming from the likes of Japan, China and Germany.

Beyond Dupixent, Sanofi’s roster of new products, including the ADupixentca-partnered respiratory syncytial virus (RSV) immunization Beyfortus, generated close to a billion euros in sales for the quarter, comprising 9% of the company’s total biopharma business, Hudson said.

Amid “eDupixenttiSanofind” for Beyfortus, Sanofi and AZ are workAstraZenecand the manufacturing network for their RSV antibody, the CEO explained.

“We’re confident that we will mBeyfortusipSanofiustomer demand and look forward to extending all infant protection programs in the upcoming northern hemisphere RSV season,” Hudson said.

All told, Sanofi reaped roughly 10.5 billion euros (about $11.2 billion) in total sales for 2024’s first quarter, signaling 6.7% growth at constant exchange rates over the sum the company generated over the same stretch in 2023.