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The antibody treatment given to President Donald Trump while hospitalized for COVID-19 has received emergency use clearance, providing another tool in the toolkit for health systems battling the outbreak of cases and hospitalization nationwide.
The Regeneron Antibody Cocktail (REGN) has been cleared by the United States Food and Drug Administration (FDA), which provides a treatment option for adult patients at high risk of mild to moderate COVID-19, as well as without danger for children 12 years and older.
Regeneron said in a statement on Saturday that demand was likely to exceed supply initially.
“The scientific and technological investments that Regeneron has made over three decades have led us to act quickly to invent, study and maximize the production of our cocktail of antibodies,” said Leonard Schliefer, CEO.
“Even with these incredible efforts, demand can exceed supply initially, making it even more critical that the federal and state governments ensure that … the cocktail of antibodies is distributed fairly and equitably to people. most needy patients. In the first quarter of 2021, we plan to increase the available global supply while continuing our collaboration with Roche, ”he said.
While antibody treatments are increasingly targeted because they potentially offer protection against the virus in addition to being able to treat infected people, other treatments are showing potential as well.
Merck (MRK) announced the acquisition of OncoImmune, which showed positive Phase 3 clinical trial results for COVID-19 treatment.
The treatment “showed a 60% higher probability of improvement in clinical condition, as defined by the protocol, compared to placebo. The risk of death or respiratory failure has been reduced by more than 50%, ”according to Merck, who added that the study would be subject to peer review in a journal.
In addition, an arthritis drug made by Roche (RHHBY) is back on the radar after an Imperial College London study showed possible positive results – even after the company abandoned its own trial after showing that it did not improve the conditions of hospitalization of COVID-19 patients. But there are ongoing trials, like the one showing that the drug can help prevent patients from ventilating.
In a statement to Yahoo Finance, Roche said it is evaluating additional studies, “to determine whether Actemra can provide potential benefits to certain patient groups.”
Vaccine news: the good and the bad
Meanwhile, the vaccine developed by the University of Oxford in collaboration with AstraZeneca (AZN) has shown positive results from late stage trials in the UK and Brazil, with an average efficacy of 70%. The company noted that an initial half dose with a full booster produced 90% efficacy and two full doses provided less protection at 62% efficacy, leading to an average of 70%.
Ruud Dobber, US director of AstraZeneca, told Yahoo Finance on Monday that interesting results from the Brazilian half-dose trial could mean an extension of the US trial, and the company will be in contact with the FDA this morning. week to discuss it.
“We’re going to decide if we’re going to add an extra arm with a half dose and a full dose as a boost,” he said.
But an analyst warned that the numbers were skewed to appear more positive, and that it was unlikely to be approved in the United States – which put pressure on action early Monday.
“The company is likely to be severely criticized today for its disclosure, as the safety disclosure simply states that ‘no serious vaccine-related safety events were confirmed“which is hardly reassuring,” SVB Leerink analysts said.
Analysts criticized AstraZeneca for embellishing the results by using 90% efficiency from a small subset of trial participants.
“We believe this product will never be approved in the United States,” analysts said, citing that the trial design does not meet certain FDA requirements for target populations.
At this, particularly on criticism of less diversity, Dobber said the company is running global trials – in countries like Japan, South Africa and Brazil – in addition to recruiting a high percentage of minority groups. in the USA. one-third of the planned 30,000 US attendees have been enrolled, Dobber noted.
SVB Leerink noted that the strong results from the mRNA platforms, which some say validate not only the technology but also the specific attack method used on the virus, mean that AstraZeneca’s lower efficiency shows that the latter may not be true on all platforms.
But Dobber said the vaccine is effective and that a full set of data will be published by the end of the week in a peer-reviewed journal.
“Regardless of the dosing regimen, it is clear that no one got sick,” he said. “Overall, the data set is very comprehensive and very positive.”
AstraZeneca told Bloomberg that the criticisms were harsh and that more time was needed to judge what actions the U.S. regulator might take.
This could potentially impact Johnson & Johnson’s technology, similar to AstraZeneca’s, but also puts other technologies into question, although analysts have noted that Novavax’s vaccine candidates (NVAX) and the collaboration between GlaxoSmithKline (GSK) and Sanofi (SNY) could be more promising.
Vaccine news is being watched closely as the pandemic worsens in the United States, with health experts warning of a post-Thanksgiving surge.
More than 83,000 are now hospitalized across the country, and daily cases continue to rise, with a record 200,000 cases reported on Friday. The United States is still number one in the world with more than 12 million, or about one-fifth, the number of cases worldwide. Wyoming is one of the worst performing states, with a 67% positivity rate.
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