Regulation & Policy

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.

Johnson & Johnson Inc has announced the selection of a lead vaccine candidate to test against COVID-19, the disease caused by the coronavirus SARS-CoV-2. It intends to start clinical studies by September at the latest. The first batches of the vaccine could be available for emergency use authorisation by early 2021, the company announced on 30 March.

The Zolgensma gene therapy for spinal muscular atrophy, which was approved by the US Food and Drug Administration in May 2019, has now received a positive review by the European Medicines Agency. Pending approval by the European Commission, it is expected to be available to treat babies and young children across the EU soon. Spinal muscular atrophy is a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement.

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.