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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.

CEO Leonard Schleifer cautioned investors during a first quarter sales and earnings call on 2 May that a US Food...

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