Pharmaceutical regulators from 17 countries have agreed in principle on the criteria that must be met before developers of candidate vaccines for the coronavirus SARS-CoV-2 start human trials. The officials held a virtual meeting on 18 March, and a summary of their conclusions was released by the European Medicines Agency on 24 March.
The European Medicines Agency has issued a statement urging the research community to give priority to large randomised controlled studies when investigating potential treatments for COVID-19 and to include all EU countries in these trials.
New guidance on the conduct of clinical trials during the COVID-19 pandemic has been published by the European Commission, the European Medicines Agency and heads of national agencies in the EU. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf, Developers including Eli Lilly and Co, have already announced delays in the start of studies and a pause in enrollment of ongoing studies.
Seven scientists drawn from six EU member states met for the first time on 18 March to advise the European Commission on how to respond to the multitude of issues facing public health authorities during the coronavirus pandemic. Among the topics discussed were managing hospital capacity, the conduct of new clinical trials, and the protection of vulnerable populations such as refugees.
Novartis has secured approval in the US for Isturisa (osilodrostat), a new treatment for Cushing’s disease, a rare disorder in which the adrenal glands make too much of the cortisol hormone. Announcing the decision on 7 March, the Food and Drug Administration said that Isturisa is the first drug to directly address this cortisol overproduction by blocking the enzyme 11-beta-hydroxylase and preventing cortisol synthesis.
A drug previously approved to treat idiopathic pulmonary fibrosis, Ofev (nintedanib), has received a new indication in the US – to treat patients with chronic fibrosing interstitial lung diseases. Announcing the decision on 9 March, the Food and Drug Administration said it was the first treatment authorised for this group of fibrosing lung diseases which worsen over time. Ofev was developed by Boehringer Ingelheim GmbH.
A new antibiotic capable of treating infections from aerobic Gram-negative bacteria has been given a positive opinion by the European Medicines Agency. Fetcroja (cefiderocol) was shown to be effective in complicated urinary tract infections, nosocomial pneumonia and in critically ill patients with confirmed carbapenem-resistant infections. It was developed by Shionogi & Co Ltd in Japan and approved by the US Food and Drug Administration in November 2019. Once the EMA positive opinion is confirmed by the European Commission, the drug will be available to health authorities in Europe.
Public health and border control officials at the European Commission currently believe that the risk of imminent transmission of the COVID-19 coronavirus across the EU is low to moderate – even as the virus continues to infect increasing numbers of people in Italy.
According to the BBC, the number of cases in Italy reached 400 on 26 February, up by 25% in just 24 hours. To date, there have been 12 fatalities.
The Type 2 diabetes medicine Trulicity (dulaglutide) has been approved in the US to treat adults with diabetes who have cardiovascular disease or are at risk of the disease. The makes Trulicity, first approved in 2014, the only Type 2 diabetes medicine that can also be used to reduce the risk of major adverse cardiovascular events.
The US Food and Drug Administration has stepped up its oversight of certain pharmacogenetic tests that make claims for treatments that are not supported by sound science. In an announcement on 20 February, the agency said that it was introducing a new table on the internet giving a list of gene-drug interactions that are based on scientific evidence. This can be viewed at https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations.