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The single-dose vaccine is indicated for use in individuals at high risk of infection. Credit: Creative Design nacional/Shutterstock. Emergent BioSolutions has received approval from the US Food and Drug Administration (FDA) for its supplemental biologics licence application for ACAM2000, (Smallpox and Mpox (Vaccinia) Vaccine, Live), expanding its use to include the prevention of Mpox. The single-dose vaccine, administered percutaneously via a bifurcated needle, is indicated for use in individuals at high risk for mpox infection. The FDA’s approval of the ACAM2000 vaccine for Mpox is based on existing human safety data and a comprehensive animal study demonstrating its efficacy. ACAM2000 was first licensed for active immunisation for smallpox disease prevention in 2007. Mpox, formerly known as monkeypox, is a viral disease native to Central and West Africa. See Also: Growth Hormone Receptor drugs in development, 2024 Interleukin 15 Receptor Subunit Alpha drugs in development, 2024 The double-stranded DNA virus belongs to the Orthopoxvirus genus within the Poxviridae family and is related to the virus that caused smallpox, which was eradicated in 1980. The recent FDA approval aligns with Emergent’s efforts to support global health, including an Expression of Interest submitted to the World Health Organization (WHO) for emergency use assessment. Following the WHO’s declaration of the Mpox outbreak as a public health emergency of international concern, Emergent is actively engaging with global health regulators. The company pledged to donate 50,000 doses of ACAM2000 to aid affected regions in Central Africa. As the primary vaccine for smallpox in the event of a bioterrorism emergency, it is a critical component of the US Strategic National Stockpile. The vaccine is also licensed in Canada, Australia and Singapore, with stockpiles maintained both domestically and internationally, ensuring readiness against potential bioterrorism threats and disease outbreaks. Emergent BioSolutions president and CEO Joe Papa stated: “The FDA approval of ACAM2000 for immunisation against mpox in high-risk individuals further strengthens and broadens our industry-leading smallpox portfolio, which includes VIGIV and TEMBEXA. “This expanded indication for ACAM2000 comes at a critical time as the global health community comes together to ensure an effective and cohesive response to the recent upsurge in mpox cases.” The company recently finalised the sale of its Baltimore-Camden manufacturing site to the Taiwanese company Bora Pharmaceuticals.

The vaccine has been available for adults over 60 years since June 2023. Credit: MargJohnsonVA/Shutterstock. The European Commission (EC) has authorised GSK ’s Arexvy for active immunisation against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50 to 59 years. The recombinant adjuvanted RSV vaccine is indicated for adults at increased disease risk. The vaccine has been available for adults over 60 years since June 2023. People with heightened risk due to underlying medical conditions such as chronic obstructive pulmonary disease, asthma, heart failure and diabetes are eligible for the vaccine. RSV is known to exacerbate existing medical conditions, potentially resulting in pneumonia, hospitalisation or even death. See Also: Growth Hormone Receptor drugs in development, 2024 Interleukin 15 Receptor Subunit Alpha drugs in development, 2024 The regulatory approval for the expanded age indication was supported by positive outcomes from a Phase III trial that evaluated the immune response and safety of the vaccine in the target age group, including those with certain underlying medical conditions. GSK has also sought to extend the use of Arexvy to the same age group in other regions, including Japan. Regulatory decisions in these geographies are currently under review. In June 2024, the US Food and Drug Administration (FDA) expanded the age indication for GSK‘s Arexvy for adults aged 50 to 59 years at higher LRTD risk. Further clinical trials are underway to assess the vaccine’s efficacy in adults aged 18 to 49 at increased risk, and immunocompromised adults aged 18 years and over, with results expected in 2024. GSK chief scientific officer Tony Wood stated: “The approval reflects the importance of broadening the benefits of RSV immunisation to adults aged 50 to 59 who are at increased risk. “RSV infection can have a significant impact on the health of older adults and particularly those with certain existing medical conditions, which can add pressure onto healthcare systems. As we enter the RSV season, we are pleased to be the first to deliver a vaccine to help protect more people in Europe from RSV-LRTD.”

GSK’s asset is specifically for CRSwNP patients whose condition is inadequately controlled with standard therapy. Credit: OleksSH/Shutterstock. Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved for GSK ’s Nucala (mepolizumab) for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP) whose condition is inadequately controlled with standard therapy. Nucala is a monoclonal antibody that acts on interleukin-5 (IL-5). The approval is based on data from the Phase III MERIT trial, which included participants from Japan, China and Russia, and further supported by data from the global Phase III SYNAPSE study. The MERIT trial’s co-primary endpoints were the variation from baseline in nasal obstruction visual analogue scale (VAS) score during weeks 49 to 52 versus placebo, and the change in endoscopic nasal polyp score at week 52. Mepolizumab significantly improved the nasal obstruction VAS score and showed a numerical reduction in nasal polyp score at week 52. See Also: Growth Hormone Receptor drugs in development, 2024 Interleukin 15 Receptor Subunit Alpha drugs in development, 2024 Improvements in patient quality of life were also observed, as measured by the 22-item Sino-Nasal Outcome Test (SNOT-22), with mepolizumab treatment versus placebo. Safety and tolerability data from the trial aligned with the known profile of mepolizumab. In Japan, mepolizumab is also approved for bronchial asthma in children aged six years or above and adults with refractory asthma inadequately controlled with standard treatments. It is also indicated for adult patients with eosinophilic granulomatosis with polyangiitis who do not respond adequately to standard treatments. GSK respiratory/immunology research and development global head and senior vice-president Kaivan Khavandi said: “The chronic and debilitating impact that chronic rhinosinusitis with nasal polyps can have on those affected is often underestimated. “This additional indication for Nucala in Japan could provide patients with an alternative treatment option to surgery or systemic steroids.” The latest development comes after GSK obtained the Singapore Health Sciences Authority’s approval for a new indication for Jemperli (dostarlimab) for use with chemotherapy in treating advanced or recurrent endometrial cancer.