The UK government has approved the use of a generic corticosteroid, dexamethasone, for the treatment of patients in hospital with COVID-19 that require oxygen, including those on ventilators. This follows the results of a clinical trial conducted by the University of Oxford which showed that the drug can reduce the risk of death of patients on ventilation by as much as 35% and those on oxygen by 20%.
Recarbrio, an antibiotic designed to treat infections caused by Gram negative bacteria, has been approved for a new indication by the US Food and Drug Administration. This is to treat both hospital acquired bacterial pneumonia and ventilator associated bacterial pneumonia which can cause chest pain and an increased need for oxygen.
The US Food and Drug Administration has approved the first drug to help image tau neurofibrillary tangles in the brain, a primary marker of Alzheimer’s disease. The radioactive diagnostic agent, Tauvid (flortaucipir F18), is indicated for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of the neurofibrillary tangles.
A new vaccine to prevent Ebola virus disease has been recommended for approval by the European Medicines Agency following a development programme financially supported by the Innovative Medicines Initiative, a public private partnership. The vaccine’s developer is Johnson & Johnson Inc. The positive opinion was issued on 29 May, just days before the United Nations Children’s Fund reported a new cluster of Ebola virus infections in the Democratic Republic of Congo (DRC).
The European Medicines Agency has signed a contract with Utrecht University in the Netherlands to gather real-world evidence on the safety and effectiveness of any new COVID-19 vaccines that are launched on the market. According to the World Health Organization, 10 candidate vaccines were in clinical development as of 30 May. Most of these molecules are in early human studies, but with pressure mounting to arrest the coronavirus pandemic, the development of the candidate vaccines is accelerating.
A new serology test designed to detect protective antibodies in people who have been exposed to the SARS-CoV-2 virus has been given emergency use authorisation by the US Food and Drug Administration, the developer Roche announced on 3 May. The test has also received a CE mark and is eligible for use in Europe. Roche said the test has a specificity of greater than 99.8% and a 100% sensitivity. The sensitivity of a diagnostic test is the proportion of true positives that are correctly identified whereas the specificity is the proportion of true negatives.
A drug originally approved to treat diabetes has now received clearance to also be used for patients with heart failure. The drug, Farxiga (dapagliflozin), is a sodium-glucose co-transporter 2 (SGLT2) inhibitor which works by helping the kidneys lower blood glucose levels. On 6 May, the US Food and Drug Administration authorised Farxiga to treat adults with heart failure with reduced ejection fraction with and without Type 2 diabetes.
A triple combination therapy for asthma Enerzair Breezhaler, which includes a digital sensor to help patients monitor their treatments, has received a positive opinion from the European Medicines Agency. Assuming formal approval by the European Commission, the drug will be available as a maintenance treatment for asthma in adult patients whose disease is not adequately controlled by a corticosteroid and a long-acting beta2 agonist.
Remdesivir has become the first antiviral drug to be approved to treat coronavirus disease 2019 (COVID-19) in the US after showing promising results in a randomised, controlled trial of 1,063 patients sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID). On 1 May, two days after the trial results were announced, the Food and Drug Administration issued an emergency use authorisation for the drug enabling it to be used for adults and children hospitalised with severe disease.
A partnership that brings together industry, pharmaceutical regulators and the US National Institutes of Health (NIH) is being created to speed up the development of therapies and vaccines for COVID-19. The planned alliance is the work of the NIH and its sister foundation, the Foundation for the NIH.