The application was based on pivotal phase III data, which confirmed the vaccine's effectiveness against respiratory syncytial virus-related lower respiratory tract illness
GSK announced that the European Medicines Agency (EMA) accepted to review the company’s marketing authorisation application (MAA) for its respiratory syncytial virus (RSV) older adult vaccine candidate.
The MAA is based on positive data from a pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial, which demonstrated excellent overall vaccine effectiveness against RSV LRTD in adults 60 years of age and older.
GSK reported that the vaccination had a good safety profile and was well tolerated. In severe disease, people aged 70 to 79 years old, persons with underlying comorbidities, and across RSV A and B strains, consistently high vaccination effectiveness was seen against LRTD.
The UK-based firm said that MAAs might be eligible for accelerated assessment if the EMA’s Committee believes the product benefits public health and therapeutic innovation.
According to GSK, if approved, GSK’s RSV older adult vaccine candidate can become the first vaccine to help protect older adults from RSV lower respiratory tract disease (LRTD).
The AReSVi-006 phase III trial is a randomised, placebo-controlled, observer-blind, multi-country trial that enrolled 25,000 participants from 17 countries.
It intended to show the efficacy of a single dose of GSK’s adjuvanted RSVPreF3 older adult investigational vaccine in adults aged 60 years and above.
The company noted that the regulatory decision is expected in Q3 2023.
Following the acceptance of the Japanese regulatory application in October 2022, this is the second significant regulatory advancement for GSK’s RSV older adult vaccine candidate.
Additionally, ViiV Healthcare, owned by GSK, with Pfizer and Shionogi as shareholders, announced that EMA has validated its MAA seeking approval of cabotegravir long-acting injectables for pre-exposure prophylaxis (PrEP).
The MAA was supported by data from two phases IIb/III multicentre, randomised, double-blind, active-controlled studies, HPTN 083 and HPTN 084 trials. Both trials evaluated the safety and efficacy of cabotegravir long-acting for PrEP in HIV-negative men.
The studies found that daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) was inferior to cabotegravir long-acting for PrEP.
ViiV Healthcare Research & Development head Kimberly Smith said: “With approximately 100,000 people in Europe newly diagnosed with HIV each year, this submission is an important step forward in offering expanded options for HIV prevention.”