The US Food and Drug Administration has approved the first drug for the prevention of acute graft versus host disease (GvHD), a condition that occurs when donor bone marrow or stem cells attack healthy tissues in a patient undergoing a treatment for certain cancers, or an organ transplant. The drug, Orencia (abatacept), is already on the market having been approved for rheumatoid arthritis in 2005. The manufacturer is Bristol Myers Squibb Co.
The New England Journal of Medicine has published data from a Phase 3 trial of Dupixent (dupilumab), a widely prescribed anti-inflammatory drug which was recently approved by the US Food and Drug Administration for children with uncontrolled moderate-to-severe asthma. Data from the trial formed the basis of a US approval and have been included in a regulatory filing with the European Medicines Agency.
The Covid-19 vaccine produced by Pfizer Inc and BioNTech SE is able to neutralise the Omicron variant of the SARS-CoV-2 virus after three doses, preliminary laboratory studies have shown. Two doses of the vaccine appear to be less effective, but still offer protection against the most severe forms of the disease, the companies reported on 8 December.
More than 43% of the global population of 7.9 billion people have been fully vaccinated against Covid-19 with all regions of the world except Africa making progress in immunising their people, according to statistics released by the European Commission on 8 December. The World Health Organization has set an immunisation target of 70% to be achieved by September 2022 at the next meeting of the United Nations General Assembly.
Merck & Co Inc and its partner Ridgeback Biotherapeutics LP published new efficacy data for their Covid-19 treatment on 26 November showing that the anti-viral drug reduced the risk of hospitalisation or death by 30%, compared with a placebo, instead of the earlier reported 50%. The updated efficacy figure is based on additional data presented to the US Food and Drug Administration. The FDA’s Antimicrobial Drugs Advisory Committee was scheduled to meet on 30 November to evaluate the latest information.
A preventive treatment for migraine, Vyepti (eptinezumab), has received a positive opinion from the European Medicines Agency – the first step towards getting an authorisation for the EU market. If approved, it will be the first and only intravenous treatment for migraine prevention in the region, the developer H. Lundbeck A/S, announced on 12 November.
A new drug has been approved by the US Food and Drug Administration for polycythemia vera, a rare disease that causes the bone marrow to make too many red blood cells, which can thicken the blood and cause clots. Besremi (ropeginterferon alfa-2b-njft) is the first approved medicine for this disease that patients can take, irrespective of their treatment history. It is also the first interferon therapy specifically approved for polycythemia vera.
Robert Califf, a professor of medicine at the Duke University School of Medicine, is to be nominated to lead the US Food and Drug Administration – a position he held during the final year of the Obama administration and will return to under the Biden presidency. A cardiologist, Dr Califf has been vice chancellor for clinical and translational research at Duke and was founding director of the Duke Clinical Research Institute, where he led many clinical trials.
The US Food and Drug Administration has amended the emergency approvals for three Covid-19 vaccine booster shots to make them available to more people. At the same time, the agency said a booster shot from any of the approved vaccines may be administered to people whose first vaccination was with a different product.
“A single booster dose of any of the available Covid-19 vaccines may be administered as a heterologous booster dose following completion of primary vaccination with a different available Covid-19 vaccine,” the agency said on 20 October.
Boehringer Ingelheim has received a second US approval for its anti-inflammatory drug Cyltezo (adalimumab-adbm), a biosimilar version of Humira, one of the most widely sold drugs in the developed world. Humira is still protected by patents which means that Cyltezo will not become commercially available in the US until 1 July 2023.