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Beyfortus Summary of Committee for Medicinal Products for Human Use Opinion Available at: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/beyfortus. Synagis - Summary of Product Characteristics (SmPC) - (eMC) [Internet]. Press Releases. All EDQM press releases. Press releases 2022 Press Release: European Commission grants first approval worldwide of Beyfortus (nirsevimab) for prevention of RSV disease in infants Download the PDF version European Commission grants first approval worldwide of Beyfortus (nirsevimab) for prevention of RSV disease in infants Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Investigator Sponsored Studies and Externally Sponsored Collaboration, Access to Quality Healthcare Sanofi Global Health, Contributing to the eradication, elimination and control of some infectious diseases, Serving the needs of patients with non-communicable diseases, Development opportunity: how Sanofi empowers you, Sanofi provides update on Phase 2 study evaluating amcenestrant in ER+/HER2- advanced or metastatic breast cancer, Press Release: Xenpozyme (olipudase alfa) approved in Japan, first and only approved therapy indicated to treat acid sphingomyelinase deficiency, Sanofi announces 300 million collaboration with Blackstone Life Sciences to advance an innovative treatment for multiple myeloma, Press Release: Sanofi and Seagen announce collaboration to develop and commercialize multiple novel antibody-drug conjugates, Press Release: Sanofi moves forward with EUROAPI listing on Euronext Paris, Sanofi recognized by S&P as one of the most sustainability-committed companies, Nirsevimab significantly protected infants against RSV disease in Phase 3 trial, Late-breaking data at 2022 AAAAI Annual Meeting show Dupixent (dupilumab) significantly improved signs and symptoms of eosinophilic esophagitis, Press release: Late-breaking Phase 3 data at AAD 2022 show Dupixent (dupilumab) significantly improved signs and symptoms of prurigo nodularis, Efanesoctocog alfa met primary and key secondary endpoints in pivotal study in hemophilia A, demonstrating superiority to prior factor prophylaxis treatment, Press Release: Sanofi continues on path to industry leadership in Immunology with Dupixent (dupilumab) as key driver, Press Release: Sanofi and IGM Biosciences Announce Collaboration Agreement for Oncology, Immunology and Inflammation Targets, Press Release: Availability of the Q1 2022 Memorandum for modelling purposes, Press Release: Sanofi unveils new corporate brand and logo unites the company under one purpose and a single identity, Press Release: Sanofi teams up with McLaren Racing to accelerate industrial excellence, FDA accepts Dupixent (dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, Press Release: FDA accepts Dupixent (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis, Olipudase alfa shown to provide sustained improvement across multiple clinical manifestations of ASMD, Update on ongoing Dupixent (dupilumab) chronic spontaneous urticaria Phase 3 program, Press Release: EUROAPI listing on Euronext Paris expected on May 6, 2022, Press Release: Sanofi continues to deliver strong business EPS growth driven by higher sales and improved margins in Q1, Filing of the 2021 U.S. Form 20-F and French Document dEnregistrement Universel containing the Annual Financial Report, Exscientia and Sanofi establish strategic research collaboration to develop AI-driven pipeline of precision-engineered medicines, Nirsevimab EMA regulatory submission accepted under accelerated assessment for RSV protection in all infants, Press Release: Positive Phase 1/2 study results of rilzabrutinib in people with immune thrombocytopenia published in The New England Journal of Medicine, Sanofi and Regeneron provide regulatory update on Libtayo (cemiplimab-rwlc) in advanced cervical cancer, Press Release: Sanofi launches first-in-pharma Diversity, Equity & Inclusion Board, Press Release: Sanofi successfully priced an inaugural sustainability-linked bond indexed on access to medicines, Late-breaking phase 3 data at 2022 AAAAI Annual Meeting show Dupixent (dupilumab) significantly reduced itch and hives in patients with chronic spontaneous urticaria, Availability of the Q4 2021 Memorandum for modelling purposes, New preclinical tolebrutinib data demonstrated superior brain penetration and potency, Positive Dupixent (dupilumab) data across five diseases with underlying type 2 inflammation to be presented at 2022 AAAAI Annual Meeting, Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine, Press Release: Dupixent (dupilumab) approved by European Commission for children aged 6 to 11 years with severe asthma with type 2 inflammation, Press Release: Strong 2021 sales and business EPS growth enabling increased investment in R&D, Nexviazyme (avalglucosidase alfa) shows sustained improvements in respiratory function and mobility in patients with Pompe disease, CHMP recommends approval of Dupixent (dupilumab) for children aged 6 to 11 years with severe asthma with type 2 inflammation, Second positive Phase 3 Dupixent (dupilumab) trial confirms significant improvements for patients with prurigo nodularis, FDA approves Enjaymo (sutimlimab-jome), first treatment for use in patients with cold agglutinin disease, Sanofis Board of Directors proposes the appointment of Carole Ferrand, Emile Voest and Antoine Yver as independent Directors, Media Update: Rezurock (belumosudil) patient-reported outcomes correlated with clinical response in chronic graft-versus-host disease, Press Release: Annual General Meeting of May 3, 2022, Press Release: Foundation S: Sanofis new philanthropic spearhead, Press Release: Update on Cialis Rx-to-OTC Switch Actual Use Trial, Press Release: Sarclisa (isatuximab) combination provides unprecedented median progression free survival in patients with relapsed multiple myeloma receiving a proteasome inhibitor therapy, Press Release: FDA grants efanesoctocog alfa Breakthrough Therapy designation for hemophilia A, Press Release: New nirsevimab data analyses reinforce efficacy against RSV, Press Release: FDA approves Dupixent (dupilumab) as first treatment for adults and children aged 12 and older with eosinophilic esophagitis, Media Update: New data from fast-growing innovative Oncology pipeline and portfolio to be presented at 2022 ASCO Annual Meeting, Press Release: Sanofi grants Regeneron worldwide exclusive license rights to Libtayo (cemiplimab), Media Update: CHMP recommends approval of Xenpozyme (olipudase alfa), the first and only treatment for ASMD, Press Release: FDA accepts Dupixent (dupilumab) for priority review in adults with prurigo nodularis, Sanofi launches 2022 global Employee Stock Purchase Plan for 86.000 people, Press Release: FDA approves Dupixent (dupilumab) as first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, Sanofi launches its first Digital Accelerator fueled by new talent and focused on growth, Media Update: Sanofi, a leader in immune-mediated rare blood disorders, to present latest data at EHA 2022, Press Release: Sanofi-GSK next-generation COVID-19 booster delivers strong immune response against variants of concern, including Omicron, Press Release: Sanofi-GSK first to report a successful efficacy study against Omicron with COVID-19 Beta-containing vaccine, Availability of the Q2 2022 Memorandum for modelling purposes, Press Release: Nexviadyme (avalglucosidase alfa) approved by European Commission as a potential new standard of care for the treatment of Pompe Disease, Press Release: Xenpozyme (olipudase alfa) approved by European Commission as first and only treatment for ASMD. Find the latest press releases from Boehringer Ingelheim on animal health, prescription medicine, pipeline and corporate news. It was used by the . 1 The approval was based on results from the Beyfortus clinical development programme, including the MELODY Phase III, MEDLEY Phase II/III and Phase IIb trials, 1,4-11 and follows the recommendation by The Committee for Medicinal Products for Human Use (CHMP . Vietnam ends discriminatory treatment against pharmaceutical products from EU Member States The EU welcomes the removal by Vietnam, as of today, of discrimination against a number of EU Member States' regulatory authorities for pharmaceutical products. Infants were randomized (2:1) to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing 5kg) intramuscular injection of Beyfortus or placebo. If you wish to continue to this external website, click Proceed. (MEDI8897 Ph2b). Hybrid Congress. Simes, E, et al. Hence, the European Commission has launched the consultation documents to obtain feedback from stakeholders in the financial services industry in order to determine whether PSD 2 requires amendments to cater for the aforementioned considerations and if so, how such amendments should be made. Click here to view the documentation. State aid: Commission approves 10 billion Polish scheme to compensate energy-intensive companies for indirect emission costs press release Press release | 13 October 2022 Second EU-US Joint Technology Competition Policy Dialogue consolidates international cooperation on competition policy and enforcement in technology sector press release Forward-looking statements are statements that are not historical facts. Beyfortus also demonstrated a comparable safety and tolerability profile to palivizumab in the Phase 2/3 MEDLEY trial.9-10,12, RSV is the most common cause of LRTI, including bronchiolitis and pneumonia, in infants.13It is also a leading cause of hospitalization in all infants, with most hospitalizations for RSV occurring in healthy infants born at term.14-17 Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalizations, and it was estimated that there were 26,300 in-hospital deaths of children younger than five years.18 RSV-related direct medical costs, globally including hospital, outpatient and follow-up care were estimated at 4.82 billion in 2017.19. Healthy preterm infants of 2935 weeks gestation were randomized (2:1) to receive a single 50mg intramuscular injection of Beyfortus or placebo. Cost of Respiratory Syncytial Virus-Associated Acute Lower Respiratory Infection Management in Young Children at the Regional and Global Level: A Systematic Review and Meta-Analysis. Journal of Virology. The press release issued by the European Commission on 26 October 2022. September 2022. Safety was assessed by monitoring the occurrence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) through 360 days post-dose.9,10 Serum levels of Beyfortus following dosing (on day 151) in this trial were comparable with those observed in the Phase 3 MELODY trial, indicating similar protection in this population to that in the healthy term and late preterm infants is likely.9 Data was published in NEJM in March 2022. Safety was assessed by monitoring the occurrence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) through 360 days post-dose.9,10 Serum levels of Beyfortus following dosing (on day 151) in this trial were comparable with those observed in the Phase 3 MELODY trial, indicating similar protection in this population to that in the healthy term and late preterm infants is likely.9 Data was published in NEJM in March 2022. EGBA Welcomes EC Commitment to Improve Digital Single Market. Viral and host factors in human respiratory syncytial virus pathogenesis. European Commission grants first approval worldwide of Beyfortus (nirsevimab) for prevention of RSV disease in infants, Beyfortus is the first and only broadly protective option against RSV for newborns and infants, Results from the clinical development program reinforce Beyfortus consistency in reducing RSV infections requiring medical care, including hospitalizations. Estimated Burden of Community-Onset Respiratory Syncytial Virus-Associated Hospitalizations Among Children Aged <2 Years in the United States, 2014-15. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Accessed October 2022. Accessed October 2022. https://clinicaltrials.gov/ct2/show/NCT03959488 (MEDLEY). . The European Commission is the first regulatory body to grant approval to Beyfortus. European Medicines Agency. Accessed October 2022. Benzinga. The news: The Heads of the National Supreme Audit Institutions Available from: https://www.ema.europa.eu/en/documents/product-information/synagis-epar-product-information_en.pdf Accessed October 2022. 2020;146:e20193611. Zobrazit ostatn orgny a instituce EU. Clinicaltrials.gov. The press release issued by 10 Downing Street on 7 November 2022. Once launched, Beyfortus will offer parents the ability to help protect their babies during their first RSV season., Iskra ReicVaccines and Immune Therapies Unit, AstraZeneca Beyfortus is the first single-dose passive immunization against respiratory syncytial virus to gain approval in Europe and is also the first and only preventative option approved for a broad infant population. Tyto strnky vyuvaj soubory cookies, kter usnaduj jejich prohlen. The approval was based on results from the Beyfortus clinical development program, including the Phase 3 MELODY, Phase 2/3 MEDLEY and Phase 2b trials and follows the recommendation by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in September 2022.3-11 In the MELODY and Phase 2b trials, Beyfortus met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV during the RSV season vs. placebo with a single dose.3-8 The safety profile of Beyfortus was similar to placebo. 2020;222(Suppl 7):S680-687. Zhang S, et al. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. Monthly update of the symmetric adjustment of the equity capital charge for Solvency II end-October 2022 Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities and Sanofi leads commercialization activities and records revenue. RSV is a common and highly contagious seasonal virus, infecting nearly all children by the age of two.1,2 Beyfortus is the first and only single-dose RSV protective option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. Beyfortus Summary of Committee for Medicinal Products for Human Use Opinion Available at: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/beyfortus. Between November 2016 and December 2017, 1,453 infants were randomized (Beyfortus, n=969; placebo, n=484) at the RSV season start. Hybrid Congress. Senhores convidados para este Congresso Lancet 2022;399:9204764. A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus (RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children. Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity. Press release 16 September 2021 Thomas TriompheExecutive Vice President, Vaccines, SanofiToday is a landmark day for RSV prevention, as decades of research and development come together in the worlds first approval of a broadly protective option against RSV disease. . Rha B, et al. Beyfortus is being developed jointly by Sanofi and AstraZeneca. Hart-Scott-Rodino waiting period expires for Sanofis acquisition of Principia Biopharma Inc. EMA accepts regulatory submission for avalglucosidase alfa, a potentially new standard of care enzyme replacement therapy for Pompe disease, Sanofi offers to acquire Kiadis, a clinical-stage company developing cell-based immunotherapy products, CHMP recommends approval of Dupixent (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis, Sanofi and Translate Bio mRNA COVID-19 vaccine candidate induced high antibody levels in preclinical studies, Sanofi and GSK to support COVAX with 200 million doses of adjuvanted, recombinant protein-based COVID-19 vaccine, New England Journal of Medicine publishes positive final results from Phase 1/2a study of BIVV001 in people with severe hemophilia A, European Commission approves Sarclisa (isatuximab) for adults with relapsed and refractory multiple myeloma, Sanofi completes Principia Biopharma Inc. acquisition, Dupixent (dupilumab) significantly reduced severe asthma attacks in children and is the only biologic to demonstrate improvement in childrens lung function in a randomized Phase 3 trial, Sarclisa (isatuximab) combination therapy demonstrated superior progression free survival and clinically meaningful depth of response in patients with relapsed multiple myeloma, Sanofi offers to acquire Kiadis for 308 million, Late-breaking ESMO presentation shows Libtayo (cemiplimab) monotherapy increases overall survival in first-line advanced non-small cell lung cancer with PD-L1 expression of 50%, Sanofi invests to make France its world class center of excellence in vaccine research and production, Sanofi Q3 2020 business EPS(1) growth of 8.8% at CER, Dupixent (dupilumab) long-term data show sustained improvement in lung function and reduction in severe exacerbations in adults and adolescents with moderate-to-severe asthma, Dupixent (dupilumab) late-breaking pivotal data showing significant improvement in eosinophilic esophagitis signs and symptoms presented for the first time at scientific meetings, Sanofi announces closing of Regeneron stock sale, New clinical and health-related quality of life data in multiple myeloma and rare blood disorders to be presented at ASH 2020, Safety and efficacy of Dupixent (dupilumab) in patients as young as 6 years with moderate-to-severe atopic dermatitis further reinforced by new data analyses presented at EADV, Sanofis virtual R&D Day event to highlight capabilities, platforms, and expertise in disease pathways to deliver potentially transformative treatments to patients, Sanofi to present growth opportunities and development strategy for Dupixent (dupilumab) in type 2 inflammatory diseases, CHMP recommends approval of Supemtek (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older, European Patent Office rules in favor of Sanofi and Regeneron concerning Praluent (alirocumab), Positive pivotal data for Libtayo (cemiplimab) monotherapy in locally advanced basal cell carcinoma featured as a late-breaking presentation at ESMO, Online availability of Sanofis half-year financial report for 2020, Dr. Jean-Christophe Rufin appointed President of the Sanofi Espoir Corporate Foundation, Sanofi and GSK initiate Phase 1/2 clinical trial of COVID-19 adjuvanted recombinant protein-based vaccine candidate, Sanofi announces positive long-term efficacy and safety data for fitusiran from interim analysis of Phase 2 extension study in people with hemophilia A and B, with or without inhibitors, Availability of the Q3 2020 Memorandum for modelling purposes, Sanofi and Regeneron provide update on Kevzara (sarilumab) Phase 3 U.S. trial in COVID-19 patients, Sanofi and GSK sign agreements with the Government of Canada to supply up to 72 million doses of adjuvanted COVID-19 vaccine, Nirsevimab reduced respiratory syncytial virus infections requiring medical care in healthy premature infants in Phase 2b trial, Sanofi to present oncology strategy, provide update on portfolio and emerging pipeline, Sanofi and Translate Bio expand collaboration to develop mRNA vaccines across all infectious disease areas, Sanofi : FDA approves Sarclisa (isatuximab-irfc) for patients with relapsed refractory multiple myeloma, COVID-19: Sanofi to donate 100 million doses of hydroxychloroquine across 50 countries, Sanofi : Filing of the 2019 U.S. Form 20-F and French Document dEnregistrement Universel containing the Annual Financial Report, Sanofi : Availability of the Pre-quarterly Results Communication, Sanofi announces pricing of Regeneron stock offering, Sanofi: FDA approves Dupixent (dupilumab) as first biologic medicine for children aged 6 to 11 years with moderate-to-severe atopic dermatitis, Sanofi joins forces with U.S. Department of Health and Human Services to advance a novel coronavirus vaccine, Sanofi: First patient outside U.S. treated in global Kevzara (sarilumab) clinical trial program for patients with severe COVID-19, Sanofi to present Phase 2 detailed results of its brain-penetrant BTK inhibitor in relapsing multiple sclerosis, Sanofi and Translate Bio collaborate to develop novel mRNA vaccine candidate against COVID-19, Sanofi: Annual General Meeting of April 28, 2020, Libtayo (cemiplimab) shows clinically meaningful and durable responses in second-line advanced basal cell carcinoma, Sanofi's Board of Directors proposes the appointment of Rachel Duan and Lise Kingo as independent directors, Sanofi to highlight pipeline programs in a series of interactive virtual sessions leading to a R&D day event, Sanofi delivers strong 2019 business EPS growth of 6.8% at CER, Sanofi: Phase 3 trial of Libtayo (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival, Sanofi and GSK to join forces in unprecedented vaccine collaboration to fight COVID-19, Sanofi names new leaders to Executive Committee, Sanofi: Availability of the Pre-quarterly Results Communication, Sanofi brain-penetrant BTK inhibitor significantly reduced disease activity in Phase 2 trial in relapsing multiple sclerosis, Libtayo (cemiplimab-rwlc) longer-term results in advanced cutaneous squamous cell carcinoma presented at ASCO 2020 show durable responses that deepen over time, FDA approves MenQuadfiTM, the latest innovation in meningococcal (MenACWY) vaccination, Sanofi successfully prices EUR 1.5 billion of bond issue, Sanofi receives positive CHMP opinion for Sarclisa (isatuximab) for the treatment of relapsed and refractory multiple myeloma, Sanofi : Positive topline results demonstrated by olipudase alfa, first and only investigational therapy in late-stage development for acid sphingomyelinase deficiency, Sanofi and Regeneron provide update on U.S. Acquisition of Synthorx, Inc. 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