GSK News & Events

GSK announced that its adjuvanted recombinant respiratory syncytial virus, RSV, vaccine, Arexvy, has been approved by the European Commission, EC, for use in adults aged 18 years and older. Arexvy was the first RSV vaccine authorised in the European Economic Area for the prevention of lower respiratory tract disease caused by RSV. It was previously approved in adults aged 60 years and above, as well as in those aged 50 to 59 years who are at increased risk for RSV disease. Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development, said: "This approval helps protect all adults aged 18 and older in Europe against RSV, a potentially serious respiratory infection that can lead to significant illness, hospitalisation and even death, particularly for those with certain underlying health conditions. GSK is proud to expand prevention options against RSV across Europe."

AI has begun helping drug companies progress through trials and regulatory submissions, Maggie Fick and Michael Erman of Reuters reports. AI is assisting with finding participants and clinical trial sites as well as drafting documents for regulators. Many drugmakers, including Eli Lilly (LLY) have entered partnerships with Nvidia (NVDA), hoping AI will also improve the success rate of new drugs. Other drug companies in the space also using AI include Novartis (NVS), GSK (GSK), Genmab (GMAB), and Teva Pharmaceutical (TEVA).

GSK announced that China's National Medical Products Administration, NMPA, has approved a new indication for Trelegy Ellipta, fluticasone furoate / umeclidinium / vilanterol, for the treatment of patients with asthma aged 18 years and older, adding to its current license for use in patients with chronic obstructive pulmonary disease, COPD. The approval means that Trelegy Ellipta is the first and only single inhaler triple therapy, SITT, approved for the maintenance treatment of both respiratory conditions in the country. Approval was based on GSK's CAPTAIN study which showed that in patients uncontrolled on inhaled corticosteroids/long-acting beta agonist, the additional bronchodilation provided by Trelegy Ellipta demonstrated significant improvements in lung function compared with fluticasone furoate / vilanterol.