Sanofi may win U.S.
approval of $3 billion eczema drug by March
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[September 26, 2016]
(Reuters) - French drugmaker Sanofi
and its U.S. partner Regeneron Pharmaceuticals could win U.S. approval
for their keenly awaited new eczema drug dupilumab, seen by analysts as
a potential $3 billion-a-year seller, by next March.
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Sanofi badly needs new products to make up for flagging sales in its
diabetes business, where its top-seller Lantus faces growing
competition.
The two companies said on Monday that the U.S. Food and Drug
Administration had accepted dupilumab for priority review for
treating atopic dermatitis (AD), a skin inflammation also known as
atopic eczema, and set a target decision date of March 29.
Dupilumab, an injectable antibody drug, is seen by investors as
perhaps Sanofi's most promising pipeline medicine, since it has
produced promising clinical results and could be first systemic
therapy for severe AD.
The drug is also being developed for severe asthma, where it will
compete with a wave of other new biotech medicines such as
GlaxoSmithKline's Nucala and Teva's Cinqair.
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Industry analysts, on average, forecast annual sales for dupilumab
of $3.0 billion by 2021, according to Thomson Reuters Cortellis.
(Reporting by Ben Hirschler; editing by Jason Neely)
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