Regulation & Policy

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.

Roche has announced plans to launch a new serology test to detect protective antibodies in people who have been exposed to the SARS-CoV-2 virus. The test is expected to be available by early May in countries that recognise the CE registration mark. The company is also applying to the US Food and Drug Administration to get emergency use authorisation for the US market.

The US Food and Drug Administration has reported positive results from a clinical investigation of synthetic swaps that might be used at the front of the nose to test for the presence of the SARS-CoV-2 virus in the general population. The swabs have been tested by a collaboration that includes the FDA; the Bill & Melinda Gates Foundation, the insurer UnitedHealth Group; and the contract research organisation Quantigen LLC. The diagnostic is a polyester-based swab developed by US Cotton, which manufactures cotton swabs.

The US Food and Drug Administration has approved a new therapy for adults and adolescents with haemophilia who do not respond to blood clotting factor replacement treatments because of neutralising antibodies.The new therapy, Sevenfact, is a recombinant factor VIIa treatment whose active ingredient has been obtained from genetically engineered rabbits. Factor VIIa is a recognised bypassing agent for patients with inhibitors to treatments for haemophilia A and B.

The US Food and Drug Administration has asked for the immediate removal from the market of ranitidine medicines, some of which are sold under the trade name Zantac, owing to the presence of an impurity which may cause cancer. The FDA decision was announced on 1 April and follows an investigation that started in September 2019. The impurity is called N-Nitrosodimethylamine (NDMA) which is a known environmental contaminant found in water and foods. At low levels it is not considered dangerous.