PARIS (dpa-AFX) - French drug major Sanofi (SNYNF, SNY) and Regeneron
Pharmaceuticals, Inc. (REGN) announced Friday that Dupixent (dupilumab) has been
recommended for European Union approval to treat patients with chronic
obstructive pulmonary disease or COPD.

The European Medicines Agency's Committee for Medicinal Products for Human Use
or CHMP adopted a positive opinion recommending the approval of Dupixent as an
add-on maintenance treatment in adults with uncontrolled COPD characterized by
raised blood eosinophils.

If approved, Dupixent would be the first-ever targeted therapy for COPD in the
EU and the first new treatment approach for this disease in more than a decade.

The European Commission is expected to announce a final decision on the Dupixent
application in the coming months.

COPD, a respiratory disease, damages the lungs and causes progressive lung
function decline. Dupixent, which is being jointly developed by Sanofi and
Regeneron, is a fully human monoclonal antibody and its development program has
shown significant clinical benefit and a decrease in type 2 inflammation in
phase 3 studies.

The companies noted that the positive CHMP opinion is supported by data from the
landmark BOREAS and NOTUS phase 3 studies that evaluated the efficacy and safety
of Dupixent in adults with uncontrolled COPD with evidence of type 2
inflammation. The primary endpoint was met in both studies, showing Dupixent
significantly reduced annualized moderate or severe acute COPD exacerbations by
up to 34% compared to placebo.

Sanofi and Regeneron noted that the use of Dupixent in COPD is investigational
and is not yet approved by global regulatory authorities.

The companies' submissions are also under review with regulatory authorities
around the world, including in the U.S. and China.

The U.S. Food and Drug Administration earlier this year accepted for Priority
Review the supplemental Biologics License Application for Dupixent as an add-on
maintenance treatment in certain adult patients with uncontrolled COPD. The
target action date is September 27.

In more than 60 countries, Dupixent has received regulatory approvals for
indications including atopic dermatitis, asthma, chronic rhinosinusitis with
nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis and
chronic spontaneous urticaria (CSU) in different age populations.

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