Source: Pharmaceutical Technology
Source: Pharmaceutical Technology
Prior to Beyfortus’ approval, the only approved RSV preventative antibody treatment for infants was AbbVie’s Synagis (palivizumab). Credit: GOLFX via Shutterstock How is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Benchmark the impact of major themes on the Biopharmaceutical industry.
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success.
Source: Pharmaceutical Technology
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The therapy can also be given to infants up to 24 months of age who are vulnerable to severe RSV disease through their second RSV season. Source: Pharmaceutical Technology
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Beyfortus is an intramuscular monoclonal antibody therapy that acts by neutralising the RSV-F protein. This prevents the unfolding of the protein, blocking viral entry. The antibody’s approval is based on data from three clinical studies (trials 03, 04 and 05) and a positive recommendation from a 9 June FDA Advisory Committee meeting. The European Medicines Agency approved the prophylactic treatment in October 2022. Regulatory authorities in China, Japan and several other countries are also assessing the therapy. Prior to Beyfortus’ approval, the only approved RSV preventative antibody treatment for infants was AbbVie’s Synagis (palivizumab), which was approved in 1998. However, AstraZeneca’s newly approved medicine is the first preventative option that specifically protects the broad infant population through its first RSV season. In a February 2023 email interview with Pharmaceutical Technology, Nancy Jaser, a senior infectious disease analyst at GlobalData, predicted that upon its approval, Beyfortus would replace Synagis as the standard of care passive immunisation for paediatric RSV patients. Beyfortus’s approval follows the FDA approval of the first RSV vaccine for older adults, GSK’s Arexvy. Patients aged 60 years and above are eligible to take the immunisation. This was followed a few weeks later by approval for Pfizer’s RSV vaccine Abrysvo, intended for the same population of individuals aged 60 years and above. Phase II data from Trial 03 (NCT02878330) demonstrated that infants treated with Beyfortus had a 6.9% lower incidence of medically attended RSV lower respiratory tract infection (MA RSV LRTI). It also demonstrated that Beyfortus decreased the risk of MA RSV LRTI by approximately 70% relative to placebo. In the Phase III (MELODY) Trial 04 (NCT03979313), this increased to 75% efficacy compared to placebo. Data was taken from the Phase II/III (MEDLEY) Trial 05, showing that the drug had a favourable safety profile. In a press release, AstraZeneca’s executive vice president Iskra Reic said: “Beyfortus represents an opportunity for a paradigm-shift in preventing serious respiratory disease due to RSV across a broad infant population in the US.” How is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Benchmark the impact of major themes on the Biopharmaceutical industry.
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success.
Source: Pharmaceutical Technology
Antigua & Barbuda (+1268)
Bosnia Herzegovina (+387)
Cape Verde Islands (+238)
Central African Republic (+236)
Dominican Republic (+1809)
Sao Tome & Principe (+239)
Trinidad & Tobago (+1868)
Turks & Caicos Islands (+1649)
United Arab Emirates (+971)
Virgin Islands - British (+1284)
Virgin Islands - US (+1340)
Bonaire, Sint Eustatius and Saba
British Indian Ocean Territory
French Southern Territories
Heard Island and McDonald Islands
Saint Helena, Ascension and Tristan da Cunha
Saint Pierre and Miquelon
Saint Vincent and The Grenadines
South Georgia and The South
US Minor Outlying Islands
-->By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Submit
Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
Please check your email to download the Report.