Full Press Release Details
Sanofi to present growth opportunities and development strategy for
Dupixent (dupilumab) in type 2 inflammatory diseases
Sanofi commercial and R&D executives will provide an overview of the growth and development strategy for Dupixent
(dupilumab) in the third of its five-part series to highlight Sanofi s progress in R&D. As announced in December 2019, Sanofi expects to deliver strong growth for Dupixent with the ambition of achieving more than 10 billion
in peak sales driven by its selective mechanism of action targeting the type 2 inflammation pathway. Sanofi co-develops and co-commercializes Dupixent with Regeneron.
By specifically targeting IL-4 and IL-13,
Dupixent s mechanism of action is uniquely suited to help address conditions driven by type 2 inflammation, said John Reed, M.D., Ph.D., Global Head of Research and Development, Sanofi. While atopic dermatitis and asthma are the
foundational diseases where Dupixent was first approved for use, great opportunity exists across multiple diseases where type 2 inflammation plays a role. We are therefore aggressively pursuing clinical evaluation of additional indications where
patients are urgently awaiting solutions for their unmet medical needs.
Today s presentation will detail five potential future line
extensions for Dupixent, including:
Part B of the Phase 3 trial is ongoing, and, if the results are positive, regulatory
submissions are expected to be filed by the end of 2022. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Dupixent for the treatment of EoE. Currently, no FDA-approved
treatments are available for this condition.
Currently, two Phase 3 studies are underway testing Dupixent, each enrolling 150 patients with PN. Topline trial results
are expected in 2021, which could support regulatory filings at the end of 2021.
Earlier this year, a 240 patient registrational study of Dupixent in CSU was initiated, and if the results are positive, regulatory filings
would be submitted in 2022.
A pivotal Phase 3 trial testing Dupixent in BP patients has been initiated. If the results
are positive, regulatory filings will be submitted in 2023+. The FDA has granted orphan drug designation to Dupixent for the treatment of BP.
these potential uses are investigational, and the safety and efficacy of Dupixent in any of these indications has not been evaluated by any regulatory authority.
The virtual investor event will be held today from 3:00-4:30 pm CET /
9:00-10:30 am EDT. Sanofi speakers include:
Joining for Q&A will be Sanofi Chief Executive Officer Paul Hudson, Jean-Baptiste de Chatillon, Sanofi Chief Financial Officer, and Bill Sibold, Global
Head of Specialty Care.
Additional information about today s Dupixent presentation can be found at: https://www.sanofi.com/en/investors/financial-results-and-events/investor-presentations/2020-dupixent-presentation
Dupixent is approved in the U.S. to treat
patients aged 6 years and older with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin (topical), or who
cannot use topical therapies; for use with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in
patients aged 12 years and older whose asthma is not controlled with their current asthma medicines; and for use with other medicines for the maintenance treatment of CRSwNP in adults whose disease is not controlled. In adolescents 12 years of age
or older, it is recommended that Dupixent be administered by or under the supervision of an adult. In children younger than 12 years of age, Dupixent should be administered by a caregiver.
Outside of the U.S., Dupixent is approved for specific patients with
moderate-to-severe atopic dermatitis and certain patients with asthma in a number of other countries around the world, including the EU and Japan. Dupixent is also
approved in the EU and Japan to treat certain adults with severe CRSwNP. The 200 mg and 300 mg pre-filled pens are currently approved in the EU.
Dupilumab Development Program
currently approved indications, Sanofi and Regeneron are also studying dupilumab in a broad range of clinical development programs for diseases driven by allergic and other type 2 inflammatory disorders, including pediatric asthma (6
to 11 years of age, Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 2/3), chronic obstructive pulmonary disease (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis
(Phase 3), chronic spontaneous urticaria (Phase 3), and food and environmental allergies (Phase 2). These potential uses are investigational, and the safety and efficacy have not been evaluated by any regulatory authority. Dupilumab is being jointly
developed by Sanofi and Regeneron under a global collaboration agreement.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness
with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
| Media Relations Contact Ashleigh Koss Tel.: +1 908 205 2572 Ashleigh.Koss@sanofi.com | Investor Relations Contact Felix Lauscher Tel.: +33 (0)1 53 77 45 45 ir@sanofi.com | |
| Quentin Vivant T l.: +33 (0)1 53 77 46 46 mr@sanofi.com |
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