AstraZeneca’s Evusheld Covid-prevention drug gets UK approval

  • 3/17/2022
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AstraZeneca has received UK regulatory approval for its long-acting Covid-19 antibody treatment Evusheld in a boost to its coronavirus portfolio, as the British-Swedish drugmaker targets greater drug development success at its new £1bn research lab in Cambridge. Aimed at preventing Covid infections in people with poor immune systems who cannot be vaccinated, Evusheld is already approved in the US, France and other countries, and the US government has ordered 1.7m doses. It is a combination of two long-acting antibodies that works by binding to the spike protein on the outside of the Sars-CoV-2 virus, which causes Covid-19. This in turn prevents the virus from attaching to and entering human cells. Evusheld was found to cut the risk of developing symptomatic Covid-19 by 77% in trials, with protection lasting for at least six months after a single dose, given as two injections, the UK’s Medicines and Healthcare products Regulatory Agency said. AstraZeneca has said a lab study showed the drug works against the Omicron variant, but the MHRA said there was insufficient data to fully evaluate this. Revenue growth from Evusheld this year is expected to offset weaker sales of AstraZeneca’s Covid-19 vaccine, developed with Oxford University, which brought in nearly £3bn last year, after the firm moved away from its not-for-profit pricing. Britain’s biggest pharmaceutical company wants to make a success of its new vaccines and antibody therapies division, which includes Evusheld, and insists that it is not trying to hive off the Covid vaccine. It has still not been approved in the US, where officials have questioned how the firm presented data on the shot’s effectiveness. Sir Mene Pangalos, a British neuroscientist and AstraZeneca’s executive vice-president of biopharmaceuticals research & development, rejected suggestions that the firm might want to offload its Covid shot to another company, even though sales are projected to fall this year. “It’s still the most widely used vaccine in the world and will continue to be a globally used vaccine, particularly in low- to middle income countries where supply chains are difficult and price is important,” he told the Guardian in an interview ahead of the company’s annual research and development day. It launched a new global competition to fund postgraduate scientists who bring innovative ideas to the firm. While the shot has been far cheaper than those of rivals Pfizer and Moderna, and is easier to store and transport, AstraZeneca has faced a barrage of negative publicity related to very rare blood clot side-effects as well as manufacturing delays soon after its rapid launch. It has recently moved to for-profit pricing in all but the poorest countries, but insists its prices are still affordable. Pangalos also confirmed in the interview that AstraZeneca’s clinical trials of new medicines are continuing in Russia and Ukraine, despite the escalating conflict. He said the company’s move to bring all lab-based scientists under one roof in Cambridge alongside new state-of-the-art facilities “should help productivity”. “It’s going to be much easier for us when we are all together, in terms of our culture, us being able work more effectively together, but also being at the heart of Cambridge and at the heart of the biomedical campus,” he said. “It will improve creativity, how happy people are, and it’s going to help take us on to the next step of our journey as an R&D organisation.” The teams developing treatments for cancer and biopharma – medicines made from biological sources such as a blood product – will be housed in the same building, while AstraZeneca’s third plank, rare diseases – the Alexion portfolio acquired last year – is based in New Haven and Boston in the US. With 16 labs and 2,200 scientists, the vast glass-clad Discovery Centre, which was unveiled by Prince Charles in November, will become the biggest science lab in Britain along with the Francis Crick Institute in London, and is part of Europe’s biggest biomedical cluster in Cambridge. Cambridge University, two hospitals and hundreds of research institutions and biotech firms are nearby. AstraZeneca’s two other big research hubs are in Gaithersburg, Maryland, and in Gothenburg in Sweden. Until now, AstraZeneca’s scientists have been scattered across nine sites in Cambridge. Half of its 4,000-strong workforce in the university town – those working on early-stage drug development – are due to move into the new centre by the end of the year. Pangalos and some other “pioneers” are already in situ. The rest will be based at Academy House in the centre of Cambridge. The company has undergone a huge transformation since Pascal Soriot became chief executive a decade ago and boosted its drug success rates. Since 2005, the proportion of molecules that have advanced from preclinical investigation to completion of late-stage clinical trials has jumped from 4% to 23%. This is well above the average industry success rate of 14% between 2018 and 2020. AstraZeneca now has 13 blockbuster drugs, each with annual sales of more than $1bn.

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