Therapy Areas: Respiratory
Pfizer reports positive Phase 3 data for ABRYSVO in adults at risk for RSV disease
9 April 2024 -

Biopharmaceutical company Pfizer Inc (NYSE:PFE) on Tuesday announced positive top-line data from the Phase 3 MONeT trial evaluating ABRYSVO in adults aged 18-59 at risk of developing severe RSV-associated lower respiratory tract disease (LRTD).

ABRYSVO met primary endpoints, demonstrating non-inferior immune response compared to the Phase 3 RENOIR study in older adults, and was well-tolerated. These findings will be submitted to regulatory agencies to seek approval for adults 18-59.

The study addressed a significant unmet need, focusing on adults with chronic conditions such as asthma and diabetes, who are at increased risk for RSV disease. Results also met diversity recruitment goals, reflecting the US population's diversity and medical conditions.

Pfizer plans to expand ABRYSVO's indication to adults 18 and older subject to regulatory approval.

These findings will be published in a scientific journal and presented at upcoming conferences, potentially positioning ABRYSVO as the first RSV vaccine for adults 18 and older.