The US Food and Drug Administration approved a second vaccine on 31 May to protect older adults against infection from the respiratory syncytial virus (RSV). The vaccine, Abrysvo, was developed by Pfizer Inc and is expected to be launched before the next RSV season which typically starts in the autumn and peaks in the winter. The decision follows the agency’s authorisation on 3 May of a vaccine for the same disease from GSK Plc.
Robert Califf, the US Food and Drug Administration Commissioner, took a strike against drug prices on 7 June saying that prices “are too high in the US” with the result that many patients, especially with cancer, are not completing their prescribed treatments because they cannot afford to do so.
The European Medicines Agency is recommending that Adakveo (crizanlizumab), a medicine for preventing vaso-occlusive crises in patients with sickle cell disease, be withdrawn from the EU market. This follows data from a post-authorisation study showing little benefit and a higher rate of adverse events. Developed by Novartis, Adakveo was given a conditional approval on 28 October 2020. Full approval was contingent on positive data from the STAND follow-up study.
The World Health Organization has declared an end to the emergency phase of Covid-19, but cautioned that risks still remain for the appearance of new variants of the SARS-CoV-2 virus. In a statement on 5 May, Tedros Adhanom Ghebreyesus, the WHO director general, said Covid-19 will no longer be categorised as a public health emergency of international concern. But its status as a pandemic will remain until these risks diminish.
Going forward, the pandemic “appears to be in transition to a more endemic situation globally,” the WHO said.
A vaccine developed by GSK Plc to protect older adults against infection from the respiratory syncytial virus (RSV) has been approved in the US and given a positive opinion in the EU – the first such treatment to be approved anywhere in the world. The vaccine, Arexvy, will be launched in the US before the next RSV season which typically starts in the autumn and peaks in the winter. Launch in Europe is expected to follow a formal decision on marketing authorisation, which will be taken by the European Commission.
Health technology assessment (HTA) bodies in the US, Canada and the UK have reached a consensus about how confidential clinical data should be handled in their public assessments of new medicines. Each of the groups operates in a different healthcare environment, but they agree that more transparency is required in the future.
US regulatory approval has been given to MaaT Pharma SA of France to start a Phase 3 trial of an experimental microbiome therapy in patients with graft-versus-host-disease, a potential complication from an allogeneic stem cell transplantation. The therapy, MaaT013, is an enema formulation consisting of samples of faeces from multiple healthy donors. The goal of the treatment is to restore gut microbiome diversity in order to help the body fight the disease.
The US Food and Drug Administration has approved the first oral microbiota product to prevent the recurrence of Clostridioides difficile (C. difficile) infection in individuals suffering repeat infection after treatment with an antibiotic. The product is made from human faeces. This is the second microbiota product targeting C. difficile infection to get a US approval in just five months. The first was a faecal transplant therapy developed by Ferring Pharmaceuticals Inc.
The US Food and Drug Administration has approved a new cell therapy to quicken the recovery of neutrophils, a subset of white blood cells in the body, and reduce the risk of infection in patients being treated for blood cancers. Called Omisirge (omidubicel), the product was developed by Gamida Cell Ltd of Israel.
A project initiated by the European Medicines Agency in 2022 to collect data on healthcare, disease prevalence, and the use of medicinal products, is entering its second year with plans to quadruple the number of studies. The project looks at real-world data, or data on a patient’s health from sources other than clinical trials, and real-world evidence, which is the analysis of this data.