Saturday, June 22, 2024

Chronic Obstructive Pulmonary Disease Treatment with Dupixent Faces Potential Delay; Regeneron Reports Stagnant Eylea Sales

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Sanofi and Regeneron’s eagerly awaited approval of Dupixent for treating chronic obstructive pulmonary disease (COPD) may face a delay, as revealed by Regeneron CEO Len Schleifer. The FDA requested additional efficacy analyses from the phase 3 BOREAS and NOTUS trials, essential for chronic obstructive pulmonary disease treatment Dupixent’s potential label expansion. The FDA accepted the application in February and designated it for priority review with a decision date of June 27.

The FDA has specifically asked for sub-population breakdowns from these trials. Schleifer assured that the analyses across these requested patient subgroups indicate a consistent and clinically meaningful reduction in chronic obstructive pulmonary disease exacerbations. The companies plan to provide the requested information “substantially sooner” than the FDA’s end-of-May deadline. However, if the FDA needs more time to review the data, the decision could be delayed by up to three months.

Schleifer explained that the FDA is particularly thorough when evaluating new classes of biologics, ensuring that no sub-population drives the overall data. Despite this rigorous scrutiny, Schleifer noted that no such issues have been identified for chronic obstructive pulmonary disease treatment Dupixent.

Regeneron Struggles with Eylea Market Share After FDA Rejection and Strong Competition from Roche’s Vabysmo

This regulatory hurdle follows a challenge Regeneron faced last year when another highly anticipated product—a high-dose version of the macular degeneration drug Eylea—was rejected by the FDA due to a manufacturing issue with a third-party drug filler. Although Regeneron quickly resolved the problem, leading to FDA endorsement less than two months later, the company has struggled to regain market share from Roche’s new bispecific drug Vabysmo.

On Thursday, Regeneron reported that U.S. sales of the Eylea franchise fell 2% year-over-year to $1.4 billion, with Eylea HD accounting for $200 million. This performance fell short of analysts’ consensus of $1.86 billion. However, there was a sequential increase for Eylea HD, with sales rising from $123 million in the previous quarter to $200 million. In contrast, Roche reported that Vabysmo sales significantly exceeded expectations, reaching 847 million Swiss francs ($927 million), up 108% year-over-year.

Schleifer highlighted that TV promotion, broad prescriber familiarity, and satisfaction with Eylea HD’s clinical profile would drive its uptake. Another positive development is the establishment of a permanent J-code for Eylea HD on April 1, which streamlines the billing and reimbursement process for Medicare Part B prescriptions. Analysts at Leerink Partners noted that a $40 million channel inventory reduction impacted first-quarter sales. If adjusted for this reduction, Eylea HD sales would have met the estimates.

Chronic Obstructive Pulmonary Disease

Regeneron’s Revenue Misses Targets as Dupixent for Chronic Obstructive Pulmonary Disease Faces Delay

Regeneron’s total revenue for the quarter was $3.14 billion, down 1% year-over-year and below analysts’ expectations of $3.22 billion. Excluding sales of the COVID-19 antibody treatment Ronapreve, revenue increased by 7%.

Despite the stagnant sales of Eylea, chronic obstructive pulmonary disease treatment Dupixent continued its strong performance. Sales for the IL-4/13 inhibitor, recorded by Sanofi, rose 24% to $3.1 billion, resulting in a 14% increase in Regeneron’s collaboration revenue from Sanofi, totaling $910 million for the period. Additionally, Regeneron’s oncology treatment Libtayo saw a 50% sales increase, reaching $244 million, putting it on track to become a blockbuster for the first time since its market entry in 2018.

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In summary, while Regeneron faces potential delays in the approval of Dupixent for chronic obstructive pulmonary disease and challenges in Eylea sales, the company continues to show growth in other areas. The rigorous evaluation of chronic obstructive pulmonary disease treatment Dupixent’s efficacy data underscores the FDA’s commitment to thorough scrutiny, ensuring that new therapies provide consistent and meaningful benefits across all patient subgroups. Regeneron remains optimistic about its pipeline and market strategies, aiming to overcome these hurdles and continue delivering innovative treatments to patients.

 

Resource: Fierce Pharma, May 02, 2024

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