HQ Team
April 9, 2024: Pfizer Inc., announced its experimental drug for treating a lower respiratory tract disease for adults between 18- to 59 years has met its primary goals in trials.
The late-stage trials of the drug Abrysvo, which evaluated a single dose, achieved “positive top-line immunogenicity and safety data,” according to a company statement.
The disease, severe respiratory syncytial virus (RSV), is associated with the lower respiratory tract. Immunogenicity and safety tests were conducted in adults who were at increased risk for RSV disease, such as those with asthma, diabetes, and chronic obstructive pulmonary disease.
Pfizer also met its diversity recruitment goals for the study providing data from participants that mirror the diverse U.S. population and had a balanced representation across underlying medical conditions.
Diverse population
The FDA legislation requires recruiting a diverse population for testing a drug.
In an updated 2020 advisory, the FDA recommended different approaches that sponsors of clinical trials for a new drug can take to increase the enrolment of underrepresented populations in their clinical trials.
Pfizer intends to submit the clinical trial data to regulatory agencies and request expansion of the age group from the current indication to 18 years of age and older.
The respiratory syncytial virus is a contagious virus and a common cause of respiratory illness. The virus can affect the lungs and breathing passages of an infected individual and can potentially cause severe illness in young infants, older adults, and individuals with certain chronic medical conditions.
New trial initiated
In the United States alone, among older adults, RSV infections account for approximately 60,000-160,000 hospitalisations and 6,000-13,000 deaths each year.
There are two major subgroups of RSV: RSV-A and RSV-B. Both subgroups cause disease and can co-circulate or alternate predominance from season to season.
In August 2023, the FDA approved Abrysvo for the prevention of lower respiratory tract disease and its severe forms caused by RSV in infants from birth up to six months of age by active immunisation of pregnant individuals at 32 through 36 weeks gestational age.
During the same month, Pfizer announced that the European Medicines Agency (EMA) granted marketing authorisation for Abrysvo for both older adults and maternal immunisation to help protect infants.
Pfizer has initiated a clinical trial evaluating the drug in children aged from two to less than 18 years who are at higher risk for RSV disease, according to the statement.
