Arexvy, GSK's global sales driver as a No. 1 adult RSV vaccine, is set to launch in Korea.

GSK Korea's Respiratory Syncytial Virus (RSV) vaccine Arexvy was recently approved by the Ministry of Food and Drug Safety (MFDS) for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.

After setting the milestone as the first RSV-LRTD vaccine, the vaccine was approved by the U.S. Food and Drug Administration (FDA) in May last year and then extended to those 50-59 years of age in June.

The approval was based on results from two Phase III studies, RSV OA=ADJ-006 and RSV OA=ADJ-004, in adults aged 60 years and older.

Study results showed, Arexvy significantly reduced the risk of RSV-LRTD by 82.6% and the risk of severe RSV-LRTD by 94.1% compared to placebo in subjects 60 years of age and older.

In addition, vaccine efficacy for RSV-A-associated LRTD events and RSV-B-associated LRTD events was 84.6% and 80.9%, respectively.

In addition, in 2 RSV seasons (from 15 days after the first dose in the Northern Hemisphere to the end of the second season), the mean follow-up period was 17.8 months, with 67.2% efficacy for RSV-LRTD and 78.8% efficacy for severe RSV-LRTD in patients aged 60 years and older.

“RSV infections can be severe and even fatal in high-risk groups, such as the elderly, and bring a major social burden,” said Dr. Won Seok Choi, professor of infectious diseases at Korea University Ansan Hospital. ”Global health authorities in the U.S., U.K., and elsewhere are continuing efforts to prevent simultaneous outbreaks of RSV, influenza, and COVID-19.”

“Older adults are at greater risk of infection due to age-related immune decline and a greater likelihood of complications,” said Professor Choi. ”Cross-infection can occur between young children and elderly grandparents, so practicing good personal hygiene and getting vaccinated early can help keep you, your family, and society safe.”

Arexvy generated KRW 2 trillion in global sales last year...Records No. 1 in global share

Currently, Arexvy’s global sales are on an upward trajectory, driven by its title as the first RSV vaccine.

According to GSK's earnings release, Arexvy’s global sales in the second quarter were GBP 62 million (KRW 108 billion). Given that the RSV season is in the third and fourth quarters, sales are expected to become greater. Last year, the company's total revenue was GBP1.15205 billion (approximately KRW 2 trillion)

GSK has raised its revenue forecast for 2024 based on the growth of its RSV vaccine and expects revenue to increase by 7-9% over last year.

In particular, the company’s share is expected to grow despite the arrival of competing vaccines from Pfizer and Moderna.

In the short term, the company plans to increase its global presence outside of the U.S. and European markets, including Japan. This includes South Korea, where it recently received approval from the Ministry of Food and Drug Safety.

Arexvy is available in a vial containing the antigen (powder) in pre-fusion form of the RSV F-protein and a vial containing the immunostimulant (AS01E, suspension), where 0.5 mL of the reconstituted vaccine is administered intramuscularly using a needle.

It can be administered in combination with the non-immune-boosting inactivated seasonal influenza vaccine, and the CDC recommends RSV vaccination for adults aged 75 and older or high-risk groups between 60 to 74 years of age.

“RSV infections are a significant physical and economic burden for high-risk groups, including the elderly, and GSK is committed to the successful launch of Arexvy to not only prevent infection in adults but also to reduce the burden of disease for patients in Korea,” said Hyunji Kwon, Head of the Vaccines Business Unit at GSK Korea.