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Tixagevimab + Cilgavimab: First Approval
1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. dru@adis.com.
Tixagevimab and cilgavimab (EVUSHELD) is an antibody combination for COVID-19 prevention. It received UK approval for specific adult groups and EU authorization for adolescents and adults, offering pre-exposure prophylaxis.
Area of Science:
- Immunology
- Virology
- Pharmacology
Background:
- COVID-19 remains a global health concern, necessitating diverse prevention strategies.
- Monoclonal antibodies offer a targeted approach to combatting SARS-CoV-2 infection.
- Development of long-acting antibody therapies is crucial for sustained protection.
Purpose of the Study:
- To summarize the development milestones of tixagevimab + cilgavimab.
- To highlight the regulatory approvals for COVID-19 pre-exposure prophylaxis.
- To document the journey leading to the first approval for prophylaxis in uninfected individuals.
Main Methods:
- Review of development data for tixagevimab + cilgavimab.
- Analysis of regulatory submission and approval timelines.
- Compilation of key efficacy and safety findings relevant to prophylaxis.
Main Results:
- Tixagevimab + cilgavimab (EVUSHELD) is an intramuscular monoclonal antibody combination.
- Received UK approval in March 2022 for pre-exposure prophylaxis in specific adult populations.
- Granted EU marketing authorization and US FDA Emergency Use Authorization for prevention in eligible adolescents and adults.
Conclusions:
- Tixagevimab + cilgavimab represents a significant advancement in COVID-19 pre-exposure prophylaxis.
- The therapy provides an important option for individuals unable to achieve adequate immunity through vaccination.
- Regulatory approvals mark a key milestone in making this long-acting antibody available for COVID-19 prevention.
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