Regulation & Policy

Emer Cooke, currently a director at the World Health Organization, has been nominated to become the new executive director of the European Medicines Agency, succeeding Guido Rasi whose term ends on 15 November. Ms Cooke is scheduled to address a committee of the European Parliament on 13 July, after which the appointment will be finalised.

The US Food and Drug Administration is to set up a trial website to provide retrospective data on how patients responded to oncology treatments during a clinical trial leading up to the approval of a new drug. The data is already used by the agency in the drug review process but to date, has not been made publically available.

Regulatory authorities in the US and EU have taken further steps to align their practices in light of the coronavirus pandemic. Officials from the two regions already hold regular conversations about issues relating to the authorisation of new medicines. Now they are broadening their discussions to consult on pandemic issues such as the use of real world evidence to better understand the epidemiology of COVID-19.

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.

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.