AstraZeneca Plc has voluntary withdrawn a bladder cancer indication for its checkpoint inhibitor Imfinzi (durvalumab) in the US, which was given an accelerated approval in 2017 but failed to show the required efficacy in a follow-up study. The Food and Drug Administration awards accelerated approvals to certain drugs, based on surrogate endpoints, but confirmation of clinical benefit needs to be verified in subsequent trials.
The US Food and Drug Administration has approved a new small molecule drug for patients with small cell lung cancer who are set to receive chemotherapy but may be at risk of damage to their bone marrow. Cosela (trilaciclib) is to be administered before chemotherapy in order to preserve bone marrow and immune system function.
The World Health Organization has granted an emergency use authorization to the Covid-19 vaccine developed by AstraZeneca Plc and Oxford University making it eligible for distribution in up to 145 low and middle-income countries. Distribution will take place through Covax (Covid-19 Vaccines Global Access), a global vaccine project being led by the Gavi public-private partnership, the Coalition for Epidemic Preparedness Innovations (CEPI) and the WHO.
Ofatumumab, a monoclonal antibody originally developed for cancer, is being recommended to treat relapsing forms of multiple sclerosis. The European Medicines Agency has given the drug a positive review based on data from two Phase 3 studies which showed that it is superior to teriflunomide (Aubagio), a marketed multiple sclerosis treatment.
A coronavirus vaccine developed by Oxford University and AstraZeneca Plc was approved by the European Commission on 29 January, only hours after the European Medicines Agency gave the product a positive opinion. The approval is the third for a Covid-19 vaccine in the EU. The other two are vaccines developed by Moderna Inc, approved on 6 January, and a vaccine developed by BioNTech SE and Pfizer Inc, approved on 21 December 2020. Authorisation of the AstraZeneca vaccine was based on data showing an efficacy rate of around 60%.
The European Commission is pressing AstraZeneca Plc for more information about why it is unable to deliver the quantities of a coronavirus vaccine, specified in a contract, to the EU member states. In a statement issued on 25 January, the commissioner for health and food safety, Stella Kyriakides, said the company’s answers to its questions about vaccine supply had thus far “not been satisfactory.”
ViiV Healthcare has received US approval for a combination drug to treat HIV-1. Cabenuva (cabotegravir and rilpivirine) is the first injectable, long-acting regimen for the treatment of the viral infection in adults who are on a stable antiretroviral regimen. It was authorised by the Food and Drug Administration after a priority review.
Verquvo (vericiguat), a drug for heart failure, has been approved by the US Food and Drug Administration. It has a novel mechanism of action which demonstrated superiority to placebo in a Phase 3 trial of 5,050 patients with symptomatic chronic heart failure and left ventricular ejection fraction of less than 45%, following a worsening heart failure event. In the trial, the drug reduced the risk of cardiovascular death or hospitalisation for heart failure, according to the developer Merck & Co Inc.
The European Commission has granted a conditional marketing authorisation for a Covid-19 vaccine developed by Moderna Inc based on clinical data showing an efficacy rate of 94.1%. The vaccine, COVID-19 Vaccine Moderna, is to be administered to people from 18 years of age. It is the second Covid-19 vaccine to be approved by the EU following a recommendation by the European Medicines Agency. The first was a vaccine developed by BioNTech SE and Pfizer Inc. Both vaccines are based on messenger RNA (mRNA) technology.
The US Food and Drug Administration has cautioned against altering the dosing regimen for Covid-19 vaccines launched on the US market, saying that any changes not supported by clinical trial data would be “concerning.” The agency specifically warned against using a single dose regimen and/or administering less than the dose studied in clinical trials.