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Dupixent COPD Approval Could Be Delayed, Regeneron Cautions

 
• By Jessica Merrill

The US Food and Drug Administration has requested additional efficacy information on the supplemental filing in the potentially large new indication.

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Regeneron signaled a possible delay for Dupixent in COPD • Source: Shutterstock

Regeneron Pharmaceuticals, Inc. has many moving parts to prioritize this year as it transitions patients to a new version of its blockbuster ophthalmology drug Eylea (aflibercept), expands the use of Dupixent (dupilumab) to a potentially big new indication in chronic obstructive pulmonary disease (COPD), and advances an interesting pipeline that includes therapies for obesity, cancer, allergy and hearing loss.

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