Regeneron Faces Setbacks as FDA Delays Eylea Decisions and Rejects Odronextamab

Regeneron Pharmaceuticals is grappling with significant challenges as manufacturing issues at a Novo Nordisk facility lead to delays in FDA decisions for its eye disease drug Eylea and a rejection for its cancer bispecific antibody, odronextamab.

Eylea Decisions Postponed Due to Manufacturing Concerns

Two FDA decisions for Regeneron's Eylea, originally expected this month, will be delayed due to problems uncovered during a mid-July FDA inspection of Novo Nordisk's recently acquired site in Bloomington, Indiana. The facility, previously owned by Catalent, has been a source of ongoing difficulties for Regeneron.

The expected approvals for Eylea HD (high-dose) include:

• Every-four-week dosing in a pre-filled syringe
• Treatment of macular edema following retinal vein occlusion

Regeneron CEO Len Schleifer expressed optimism about a quick resolution, describing the plant issues as "procedural." He stated, "Novo has been in communication with the FDA and expects to file its comprehensive and robust response next week."

Despite the setback, Regeneron reported growth in U.S. sales of Eylea HD, which increased 29% to $393 million in the second quarter. However, the delay comes at a critical time for Eylea, which has lost considerable market share to Roche's Vabysmo. In the second quarter, the Eylea franchise generated revenue of $1.15 billion, down 25% year over year.

Odronextamab Faces Third FDA Rejection

The manufacturing issues at the Bloomington plant have also led to an FDA rejection of Regeneron's blood cancer bispecific antibody, odronextamab. This marks the third complete response letter for the CD20xCD3 bispecific antibody, following previous rejections due to concerns about confirmatory trials.

Broader Implications for the Pharmaceutical Industry

The situation at the Bloomington facility, which produced 70 billion doses last year for numerous top biopharmaceutical companies, could have far-reaching consequences. Schleifer suggested that other products manufactured at the site and due for approval might face similar FDA rejections.

A Novo spokesperson confirmed that the FDA conducted a "general, routine and unannounced" inspection at the facility, resulting in a Form 483 list of inspectional observations. The company is preparing a comprehensive response to address the concerns raised.

Despite these challenges, Regeneron reported overall sales of $3.68 billion in the second quarter, a 4% increase year over year. The continued success of Dupixent, partnered with Sanofi, has helped offset the decline in Eylea sales, with Dupixent seeing a 22% sales boost to $4.34 billion.