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Sanofi and Regeneron's Dupixent scores in Europe as the first biologic to treat COPD

2024-07-03

上市批准临床3期临床结果

With Europe's approval of Regeneron and Sanofi's Dupixent to treat chronic obstructive pulmonary disease, it becomes the first biologic option for the condition, which is the third-leading cause of death worldwide.

After more than a decade wRegeneroneatmeSanofiancDupixenthronic obschronic obstructive pulmonary diseaseo have been approved by regulators on either side of the Atlantic within a week.

Wednesday, the European Medicines Agency (EMA) signed ofchronic obstructive pulmonary disease (COPD)y blockbuster Dupixent to treat COPD, which restricts airflow from the lungs and leaves patients struggling to breathe.

This comes seveEuropean Medicines Agency (EMA)ed a long-awaitRegeneronom thSanofifor Ohtuvayre, a dual inhibitor oDupixentosphodiestCOPDe 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes.

“After more than a decade ofVerona Pharmatment advancements for those living FDAh uncOhtuvayre COPD, we are now in a newphosphodiesterase 3 (PDE3) for phosphodiesterase 4 (PDE4) enzymese the addition of innovative, new treatments such as Dupixent to help manage this progressive and irreversible disease,” Tonya Winders, CEO of the Global Allergy & Airways Patient Platform, said in Sanofi and Regeneron's press release.

The nod for Dupixent—which becomes the first biologic and first targeted therapy to treat COPD—COPDs after U.S. regulators delayed their decision date on the drug by three months, from June 27 to Sept. 27. In doing so, the agency asked thDupixenties to show more data from two trials.Sanofi Regeneron

Regulators fDupixentEMA have been satisfied with the phase 3 results, however. On the sameCOPD in May that the companies announced the delay in the U.S., Europe’s Committee for Medicinal Products for Human Use gave a thumbs-up to Dupixent.

Dupixent has been apEMAved as an add-on maintenance treatment with current therapies, which include inhaled corticosteroids, which reduce inflammation, and bronchodilators, which relax muscles in the lungs and widen the airways. BDupixentlators include long-acting beta agonists and long-acting muscarinic agonists.

Dupixente, the approval in the U.S. for Verona’s Ohtuvayre covers the treatment as an add-on drug or a monotherapy.inflammation long-acting beta agonists

Duxpixent was shown in the BOREAS and NOTUS trials to reduce moderate or severe exacerbations over 52 weeks of treatment by 30% and 34% respectively, compared to placebo. Those results compare to a 40% reduction in flare-ups in Verona’s two trials of after 24 weeks of treatment with Ohtuvayre.

Analysts from GlobalData stressed the importance of Dupixent, as a biologic, ending the “current gap in the market for COPD."Ohtuvayre

“Key opinion leaders (KOLs) interviewed by GlobalDatDupixenthared optimistic views on Dupixent, noting that its novel pCOPDay presents anti-mucous effects, which is an additive value, supplementing its anti-eosinophil effects,” Asiyah Nawab, a pharma analyst at GlobalData, wrote.

Three months ago, analysts at Evercore ISI projected that a COPD nod would add a potenDupixentes boost of $3.5 billion annually for Dupixent, bringing its peak sales potential to $20 billion. Meanwhile, GlobalData pegs Dupixent’s sales to reach $23.6 billion by 2030.

Dupixent, which has been on the market for seven years, has COPDered approvals to treat eczema and asthma along with rarer conditionDupixents rhinosinusitis, eosinophilic esophagitis and prurigo nodularis. Dupixent rankDupixent in worldwide sales last year with a global haul of $11.6 billion.

Dupixentoval in Europe will open Dupixent’s use to more than 200,000 patients with COPD.eczemaonditasthma the world’s third-leading cause of drhinosinusitis eosinophilic esophagitis prurigo nodularis Dupixent

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