Regulatory GSK’s Adult Shot Arexvy Bags European Approval

GSK’s Adult Shot Arexvy Bags European Approval

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With Arexvy, GSK has achieved the same status in Europe as it did with the desired world-first authorization it received for its adult respiratory syncytial virus (RSV) vaccine in the U.S.

The authorization applies to individuals in 30 European nations who are 60 years of age or older. Data from the phase 3 ARsSVIi-006 study, which helped the injection receive recent U.S. clearance, supports it. In the trial, older persons with at least one underlying medical condition showed overall vaccination effectiveness between 82.6% and 94.6%.

According to a press statement from GSK, the “major public health interest” in avoiding RSV sickness led to the fast-tracking of the Arexvy application in Europe. The European Commission’s decision, which was unexpectedly swift, comes in response to the European Medicines Agency’s (EMA) favorable judgment from the Committee for Medicinal Products for Human Use (CHMP) in April.

According to GSK, the virus results in nearly 300,000 hospital admissions and 20,000 on-premise deaths per year in this age range across Europe. This population witnesses approximately 3 million cases of RSV respiratory infection annually; as these individuals age, so does the pressure and impact on healthcare systems. The company plans on launching the shot prior to the start of the RSV season in the autumn.

Tony Wood, GSK’s Chief Scientific Officer, stated, “Thousands of older adults across Europe suffer serious respiratory illness due to RSV each year. This authorization for Arexvy means eligible adults can be vaccinated against RSV disease for the first time, reinforcing GSK’s long history of vaccine innovation.” He added that the company’s robust manufacturing capacity and scale, including from their vaccine-producing site in Belgium, make it possible to deliver the vaccine rapidly to those in need.

Dr. Alberto Papi, who teaches respiratory medicine at the University of Ferrara, added that most individuals suffer from cold-like symptoms as a result of RSV. However, older adults and those with certain medical issues are at greater risk; for them, RSV’s impact can be much more brutal, leading to multiple respiratory infections. This makes it all the more important that a vaccine is now available to protect older individuals throughout Europe from this deadly disease, he added.

When Arexvy received FDA clearance in May, Pfizer and its competitor shot Abrysvo were hard on its heels. Abrysvo has now received the green light in the U.S. as well. Pfizer will introduce its injection in the country this autumn, in the same timeframe as Arexvy.

Meanwhile, both firms are awaiting recommendations from the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention, which will determine future vaccination regimens.

On its first-quarter results call, GSK stated that it has “millions” of Arexvy portions ready to ship. It is still awaiting data demonstrating the shot’s efficiency across numerous RSV seasons, but officials have stated that it is looking at enormous revenue potential.

Other regulatory assessments for Arexvy are underway in Japan and numerous other countries, according to GSK.

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