Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, these children can still experience coughing, wheezing, and difficulty breathing. Patients were allowed to enroll regardless of PD-L1 expression status, and 78% of patients had squamous cell carcinoma and 22% had adenocarcinoma. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. : +33 (0)1 53 77 94 74. mr@Sanofi.com : Sanofi Investor Relations. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. Sanofi Media Relations Nicolas Kressmann Tel. The target action date for the FDA decision is October 21, 2021 and the EU regulatory submission for children aged 6 to 11 years with asthma is planned for Q1 2021. MIT Media Relations. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. Sanofi, Empowering Life : Media Relations Contacts Quentin Vivant Tel. Kyra Obolensky. In the U.S., Libtayo is approved for certain patients with advanced stages of CSCC, BCC and NSCLC with ≥50% PD-L1 expression. In children younger than 12 years of age, Dupixent should be administered by a caregiver. : +1 (908) 205-2572 Ashleigh.Koss@sanofi.com Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. By continuing to browse this website, you agree to the use of such cookies. Sanofi Media Relations Nicolas Kressmann Tel. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. Sanofi Media Relations. Other AEs that occurred more often in the Libtayo group and in at least 10% of patients were fatigue (17% Libtayo, 16% chemotherapy), urinary tract infections (12% Libtayo, 9% chemotherapy), back pain (11% Libtayo, 9% chemotherapy) and arthralgia (10% Libtayo, 3% chemotherapy). No new Libtayo safety signals were observed. Phone: 202-994-6460 Fax: 202-994-9025 E-mail: [email protected] Sanofi Forward-Looking Statements . : +1 (908) 205-2572 Ashleigh.Koss@sanofi.com Investor Relations … PARIS and TARRYTOWN, N.Y. – March 15, 2021 – Positive results demonstrating an overall survival (OS) benefit from the Phase 3 trial investigating Sanofi and Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) monotherapy compared to chemotherapy in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic, were announced today. The trial will be stopped early based on a unanimous recommendation by the Independent Data Monitoring Committee (IDMC), and the data will form the basis of regulatory submissions in 2021. : +33 (0)1 53 77 46 46 mr@sanofi.com Nicolas Kressmann Tel: +1 (732) 532-5318 Nicolas.Kressmann@sanofi.com Investor Relations Contacts Paris To date, dupilumab has been studied in more than 10,000 patients across 50 clinical trials in various chronic diseases driven by type 2 inflammation. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. Sanofi IR main line: Tel: +33 (0)1 53 77 45 45 investor.relations@sanofi.com https://www.sanofi.com/en/investors/contact Regeneron Media Relations Contact Sharon Chen Tel: +1 914-847-1546 Sharon.Chen@regeneron.com Regeneron Investor Relations Contact Mark Hudson Tel: +1 914-847-3482 Mark.Hudson@regeneron.com Sanofi Forward-Looking Statements Sanofi, Empowering Life Sanofi Media Relations Contact Sally Bain Tel. Sanofi, Empowering Life Sanofi Media Relations Contact Sally Bain Tel. : +1 (781) 264-1091 sally.bain@sanofi.com Sanofi Investor Relations Contacts Paris Eva Schaefer-Jansen Arnaud Delepine Yvonne Naughton Sanofi Investor Relations Contacts North America Felix Lauscher Fara Berkowitz Suzanne Greco IR main line: Tel. By continuing to browse this website, you agree to the use of such cookies. The FDA also recently authorized the use of Libtayo as the first immunotherapy indicated for patients with basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate, whose cancer is either locally advanced (full approval) or metastatic (accelerated approval). Translate Bio Media Relations Maura Gavaghan Tel: +1 (617) 233-1154 mgavaghan@translate.bio Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematology, infectious diseases and rare diseases. Almost all cases are caused by human papillomavirus (HPV) infection, with approximately 80% classified as squamous cell carcinoma (arising from cells lining the bottom of the cervix) and the remainder largely adenocarcinomas (arising from glandular cells in the upper cervix). : +33 (0)1 53 77 45 45. ir@Sanofi.com. “This landmark clinical achievement will bring hope to women with advanced cervical cancer who are often younger than patients with other cancers. All the contacts. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. “We are committed to developing therapies for cancers with high unmet needs including patients with advanced cervical cancer,” said Peter C. Adamson, M.D., Global Development Head, Oncology and Pediatric Innovation at Sanofi. Sanofi: Sanofi Media Relations Contact Ashleigh Koss Tel. : +1 (781) 264 1091 sally.bain@sanofi.com. They are also at risk for life-threatening severe asthma attacks that can lead to hospitalization and emergency room visits, and may require the use of systemic corticosteroids which carry significant risks when used long term. : +1 (732) 532 53-18 Nicolas.Kressmann@sanofi.com. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority. The Corporate Media Relations Lead will be responsible for a specific portfolio of activities which could include one or more of Sanofi’s global business units and/or divisions described above. This website uses cookies to track its audience and improve its content. FDA accepts Dupixent® (dupilumab) for review in children with moderate-to-severe asthma. Key responsibilities will include. The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. PARIS and TARRYTOWN, N.Y. – March 4, 2021 - The U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Media Relations Contacts Sandrine Guendoul Tel. Tel. +33 (0)1 53 77 46 46 • mr@sanofi.com. This collaboration brings together Sanofi Pasteur’s leadership in vaccines and Translate … Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced stages. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. Sanofi Media Relations Contacts Ashleigh Koss Tel. Sanofi, Empowering Life Sanofi Media Relations … In the U.S., approximately 75,000 children aged 6 to 11 years are living with uncontrolled moderate-to-severe asthma, which can carry a significant burden for children and their families. Compared to chemotherapy, patients receiving Libtayo experienced: The primary endpoint for the trial was OS, analyzed first among patients with squamous cell carcinoma, then in the total population. The Corporate Media Relations Lead will be responsible for a specific portfolio of activities which could include one or more of Sanofi’s global business units and/or divisions described above. Sanofi Media Relations Contact Ashleigh Koss Tel: +1 (908) 981-8745 Ashleigh.Koss@sanofi.com Fidia Farmaceutici’s Press Office & PR Relations - Weber Shandwick Silvia Coltellaro Tel: +39 342 7402510 scoltellaro@webershandwickitalia.it Elisa Franchi Tel: +39 335 7173967 efranchi@webershandwickitalia.it Sanofi Investor Relations Contacts Paris Media Relations Contacts Sally Bain Tel. Media Contacts. Tel. This communication contains forward-looking statements. Sanofi Media Relations Contact Sally Bain Tel. Sanofi Media Relations … : +1 (908) 205-2572 ashleigh.koss@sanofi.com Sanofi Investor Relations Contacts Paris … investor.relations@sanofi.com. The five most common AEs were anemia (25% Libtayo, 45% chemotherapy), nausea (18% Libtayo, 33% chemotherapy), fatigue (17% Libtayo, 16% chemotherapy), vomiting (16% Libtayo, 23% chemotherapy) and constipation (15% Libtayo, 20% chemotherapy). 75008 Paris FRANCE. The sBLA is supported by data that include pivotal Phase 3 results evaluating the efficacy and safety of Dupixent in addition to standard-of-care maintenance therapy in children with moderate-to-severe asthma with type 2 inflammation, characterized by elevated blood eosinophil levels and/or raised fractional exhaled nitric oxide (FeNO) levels. Per a protocol-specified interim analysis, the IDMC reviewed OS data when approximately 85% of events had occurred among patients with squamous cell carcinoma. Proactive and reactive relationships with journalists; As the Social Media Experience Planner, you need to work with brands and agencies to develop best-in-class social programs designed to deliver goals based on a holistic consumer experience plan. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Felix Lauscher. Libtayo is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. Libtayo monotherapy is being investigated in trials in adjuvant CSCC and neoadjuvant CSCC, as well as in trials combining Libtayo with either conventional or novel therapeutic approaches for both solid tumors and blood cancers. 54 rue La Boétie. You are a journalist and have a question about Sanofi, please contact the Global Media Relations team: please note the contact details are only for Medias. This is the fourth patient population in which Libtayo has shown clinical benefit and we look forward to submitting the results to regulatory authorities later this year.”. Sanofi: Sanofi Media Relations Contact Ashleigh Koss Tel. Sanofi and Ablynx Forward-Looking Statements . Across all approved indications globally, more than 200,000 patients have been treated with Dupixent. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. : +1 732-532-5318 : +1 (908) 205 2572 ashleigh.koss@sanofi.com Quentin Vivant Tel. Translate Bio Investor Relations Teri Dahlman Tel: +1 (617) 817-8655 tdahlman@translate.bio. : +1 (732) 532 53-18 Nicolas.Kressmann@sanofi.com. The European Medicines Agency is assessing regulatory submissions for Libtayo monotherapy in advanced NSCLC with ≥50% PD-L1 expression and locally advanced BCC following treatment with an HHI, with European Commission decisions expected by mid-2021. : +1 (781) 264-1091 sally.bain@sanofi.com Regeneron Media Relations Contact Taylor Ramsey Tel: +1 (914) 409-2381 taylor.ramsey@regeneron.com Sanofi, Empowering Life Sanofi Media Relations Contacts Ashleigh Koss Tel. The generic name for Libtayo in its approved U.S. indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the FDA. Key responsibilities will include. : +1 (908) 981-8745. mr@sanofi.com : Sanofi Investor Relations Contact. Adverse events in the Phase 3 trial that were more commonly observed with Dupixent included injection site reactions, viral upper respiratory tract infections and eosinophilia. This is reflected in the trial where the average age was 51.”. Uncontrolled moderate-to-severe asthma can impair lung function, and can interfere with day-to-day activities, such as sleeping, attending school and playing sports. This will include leading social and influencer strategy, content strategy, managing project timelines and setting benchmarks to measure success. Media Relations Contacts Sandrine Guendoul Tel. The trial included women from 14 countries: the U.S., Japan, Taiwan, South Korea, Canada, Russia, Poland, Spain, Brazil, Australia, the UK, Italy, Greece and Belgium. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. The media relations team is happy to assist journalists covering MIT. Dupixent is also approved in the EU and Japan to treat certain adults with severe CRSwNP. : +33 (0)1 53 77 46 46 mr@sanofi… Sanofi, Empowering Life. Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed in women between the ages of 35 and 44. This is the largest Phase 3 randomized clinical trial in advanced cervical cancer and included women (median age: 51 years) with either squamous cell carcinoma or adenocarcinoma. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases. 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. Support from the Sanofi Espoir Foundation and collaboration with the Ministry for Europe and Foreign Affairs, Tulipe Association, UNICEF and the French Embassy These potential uses are under clinical investigation, and the safety and efficacy of dupilumab in these conditions have not been fully evaluated by any regulatory authority. Outside of the U.S., the generic name for Libtayo in its approved indication is cemiplimab. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. The Director of Media Relations is responsible for leading media relations for the strategy of the agency. “Combined with data from our non-melanoma skin cancer and lung cancer studies, these data contribute to the growing evidence demonstrating the significant potential of Libtayo to treat a spectrum of difficult-to-treat cancers.”. Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. In the U.S. 14,500 new patients are diagnosed annually, and approximately 4,000 women die each year. Sanofi Media Relations Contact. This open-label, randomized, multi-center, Phase 3 trial investigated Libtayo monotherapy versus an investigator’s choice of chemotherapy in patients with recurrent or metastatic cervical cancer that has progressed on platinum-based chemotherapy. Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. : +1 (908) 205 2572 ashleigh.koss@sanofi.com Sally Bain Tel. “Libtayo monotherapy is the first medicine to demonstrate an improvement in overall survival in women with recurrent or metastatic cervical cancer following progression on platinum-based chemotherapy in a Phase 3 trial,” said Krishnansu S. Tewari, M.D., Professor and Director of the Division of Gynecologic Oncology at the University of California, Irvine and a trial investigator. Patient Centered Outcomes and Innovation at Sanofi Washington DC-Baltimore Area. /PRNewswire/ -- Sanofi has won the prestigious International Society for Pharmaceutical Engineering (ISPE) ... Media Relations Contact Nicolas Kressmann. Click here for more information on cookies, Libtayo is the first immunotherapy to demonstrate improved overall survival in patients with cervical cancer, reducing the risk of death by 31% compared to chemotherapy, Trial enrolled patients with advanced cervical cancer regardless of PD-L1 status, Fourth cancer type where Libtayo has positive pivotal data; regulatory submissions planned in 2021, Median 12.0 months survival for Libtayo (n=304) compared to 8.5 months for chemotherapy (n=304); hazard ratio (HR): 0.69; 95% confidence interval (CI): 0.56-0.84 (p<0.001), Median 11.1 months survival for Libtayo (n=239) compared to 8.8 months for chemotherapy (n=238); HR: 0.73; 95% CI: 0.58-0.91 (p=0.003), Median 13.3 months survival for Libtayo (n=65) compared to 7.0 months for chemotherapy (n=66); HR: 0.56; 95% CI: 0.36-0.85 (p<0.005; not adjusted for multiplicity). Translate Bio Media Relations Maura Gavaghan Tel: +1 (617) 233-1154 mgavaghan@translate.bio. Outside of the U.S., Libtayo is approved for certain patients with advanced CSCC in the European Union and six other countries, including Australia, Brazil, the United Kingdom and Canada. Proactive and reactive relationships with journalists; : +1 (781) 264-1091 [email protected] Sanofi Investor Relations Contacts Paris Eva Schaefer-Jansen Arnaud Delepine Yvonne Naughton. Alnylam Pharmaceuticals, Inc. (Investors and Media) Christine Regan Lindenboom, +1-617-682-4340 or (Investors) Josh Brodsky, +1-617-551-8276 or Sanofi (Media Relations) Ashleigh Koss Tel. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis and eosinophilic esophagitis. Patients were randomized to receive Libtayo monotherapy (350 mg every three weeks) or an investigator’s choice of commonly used chemotherapy (pemetrexed, vinorelbine, topotecan, irinotecan or gemcitabine). In June 2020, the two Companies built upon the existing collaboration to pursue novel mRNA vaccines to broadly address current and future infectious diseases. 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. Phone: 617-253-2700 Email: expertrequests@mit.edu Located in the MIT News Office MIT Media Relations Staff Directory. In 2018, Libtayo was approved as the first systemic treatment for certain patients with advanced cutaneous squamous cell carcinoma (CSCC). Discontinuations due to AEs occurred in 8% of Libtayo patients and 5% of chemotherapy patients. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes, including pediatric asthma (6 to 11 years of age, Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3) and food allergies (Phase 2). Sanofi, Empowering Life Sanofi Media Relations Contacts Ashleigh Koss Tel. Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. : +33 (0)1 53 77 45 45. ir@sanofi.com. Office of Media Relations 2000 Pennsylvania Avenue NW Suite 300 Washington, D.C. 20006. Sanofi Investor Relations Contacts Paris It is estimated that approximately 570,000 women are diagnosed with cervical cancer worldwide each year. Sanofi Media Relations Contact Sally Bain Tel. Click here for more information on cookies, Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to improve lung function in children aged 6 to 11 years with asthma in a randomized Phase 3 trial, while also further adding to the well-established safety profile of Dupixent, Dupixent has the potential to be a best-in-class treatment option in this younger population of children aged 6 to 11, Acceptance represents another milestone in the development of Dupixent in addressing diseases driven by type 2 inflammation.