LONDON (ShareCast) - (Sharecast News) - Shares in pharmaceuticals giant GSK were in the green on Friday morning, after the European Medicines Agency (EMA) accepted marketing authorisation applications for RSV and HIV.
The FTSE 100 company said the EMA had validated the application for its respiratory syncytial virus (RSV) older adult vaccine candidate under accelerated assessment.

It also validated an application for cabotegravir long-acting injectable for the prevention of HIV, submitted by ViiV Healthcare.

ViiV is majority-owned by GSK, with PFizer and Shionogi as shareholders.

For the RSV vaccine, the company said a European regulatory decision was expected in the third quarter of 2023.

If approved, it said the candidate had the potential to be the first vaccine available to help protect older adults from RSV lower respiratory tract disease.

The application was based on positive data from a prespecified interim analysis of the pivotal AReSVi-006 phase 3 trial, which showed high overall vaccine efficacy against RSV lower respiratory tract disease in adults aged 60 years and older.

GSK said the vaccine was well-tolerated with a favourable safety profile, with the most frequently observed solicited adverse events being injection site pain, fatigue, myalgia, and headache.

Consistent high vaccine efficacy was observed against lower respiratory tract disease in severe disease, adults aged 70 to 79 years, adults with underlying comorbidities, and across RSV A and B strains.

"This is the second major regulatory development for GSK's RSV older adult vaccine candidate following Japanese regulatory submission acceptance in October," the board said in its statement.

"GSK's RSV older adult vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's proprietary AS01E adjuvant.

"There are currently no RSV vaccines for older adults approved anywhere in the world."

Looking at ViiV's application, GSK said the EMA had validated its marketing authorisation application for approval of cabotegravir long-acting injectable for pre-exposure prophylaxis (PrEP), to reduce the risk of sexually-acquired HIV-1.

Cabotegravir long-acting for HIV prevention is administered six times per year, after initiation.

It said the submission was supported by data from two international phase 2b and 3 multicentre, randomised, double-blind, active controlled studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in HIV-negative men who have sex with men, transgender women, and cisgender women who were at increased risk of HIV.

The studies demonstrated that cabotegravir long-acting for PrEP was superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), with clinical trial participants experiencing a 69% lower rate of HIV acquisition in HPTN 083, and a 90% lower rate in HPTN 084.

Cabotegravir long-acting for PrEP is currently approved in the US, Australia and Zimbabwe as Apretude.

"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," said ViiV Healthcare head of research and development Kimberly Smith.

"Long-acting prevention options, if used appropriately and at scale, could have the potential to transform the shape of the HIV epidemic and we look forward to continuing to work with community groups, governments and regulatory authorities to make this option available for those who need it."

At 0947 BST, shares in GSK were up 2.12% at 1,416.4p.

Reporting by Josh White for Sharecast.com.

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