AstraZeneca says COVID-19 drug helps cut risk of severe disease, death | TheHill


The Hill 11 October, 2021 - 07:09am

AstraZeneca logs encouraging results in trial of its COVID-19 drug

The Times of Israel 11 October, 2021 - 09:13pm

The drug, called AZD7442, is a combination of two antibodies given as an injection.

AstraZeneca said it's the only drug of its kind shown to both prevent and treat COVID-19.

AstraZeneca's antibody drug cut the risk of severe COVID-19 by at least 50% in a late stage study, the company announced on Monday.

The injection, called AZD7442, contains two different antibodies developed from the the blood of people who previously contracted COVID-19. It's the first drug of its kind shown to both prevent and treat COVID-19 in late-stage trials, the company said in a press release.

The company has already requested Food and Drug Administration (FDA) approval to use AZD7442 to prevent COVID-19, after late-stage trial results in August showed it reduced the risk of COVID-19 with symptoms by 77%.

It would now discuss the latest data with health authorities, it said.

The results come after Merck, the US pharmaceutical company, said on Monday it would ask the FDA to authorize its oral COVID-19 pill, which halved the risk of hospitalization or death in a trial.

The latest AstraZeneca results, from the TACKLE trial, showed that the risk of severe COVID-19 or death was halved if people took the drug within seven days of COVID-19 symptoms, AstraZeneca said. Out of 407 people who got the drug, 18 developed severe COVID-19 or died - compared with 37 of 415 people who got a saline injection.

If AZD7442 was given earlier, within five days of symptoms, the risk of severe COVID-19 was reduced by 67%, the company said. On this timing, nine of 253 participants in the AZD7442 group got severe COVID-19 or died, compared with 27 out of 251 in the placebo group.

AstraZeneca tested the drug on 822 adults with mild to moderate COVID-19 in 13 countries, including the US and UK, it said. The drug, which works by stopping the virus that causes COVID-19 from binding to the body's cells, was "generally well tolerated," it said in the release. It didn't detail any side effects.

Mene Pangalos, executive vice president at AstraZeneca, said in a statement that "early intervention with our antibody can give a significant reduction in progression to severe disease, with continued protection for more than six months."

AstraZeneca looked at the drug's impact at day 29 of the TACKLE study, which is expected to follow participants for up to 15 months. AstraZeneca's early stage studies have previously shown that antibodies last at least nine months after the drug is given.

Penny Ward, visiting professor in pharmaceutical medicine at Kings College, London, said in a statement that long lasting protection, up to 12 months, may be "a useful addition for immune-suppressed individuals whose response to vaccination is suboptimal."

Most people in the trial, 90%, had comorbidities that put them at high risk of severe COVID-19, including cancer, diabetes, obesity, chronic lung disease or asthma, cardiovascular disease, or immunosuppression, and 13% were aged over 65, AstraZeneca said.

Ward said that unlike oral pills, monoclonal antibody treatments given as an injection, such as AstraZeneca's, don't interfere with other medicines. This "may potentially make administration simpler for these patients," she said.

Read the original article on Business Insider

The European Medicines Agency (EMA) said on Monday it will assess the risks and benefits of the drug, called Ronapreve, and it could issue an opinion within two months. It belongs to a class of drugs called monoclonal antibodies that mimic natural antibodies produced by the body to fight off infections. The EMA said it was assessing clinical data investigating the effectiveness of the drug in preventing hospitalisation in outpatients, and another study looking at effectiveness in preventing COVID-19 in adults and children at risk of infection from a household member diagnosed with the disease.

State experts concluded that the man charged with killing 10 people at a Colorado supermarket is not competent to stand trial but a judge granted prosecutors' request for his mental health to be evaluated a second time, according to court filings released Monday. The initial evaluation report was not released but, according to a filing by prosecutors, the experts provisionally diagnosed Ahmad Alissa, 22, with an unspecified mental health condition that “limit(s) his ability to meaningfully converse with others" and concluded that he is not currently able to assist his lawyers in defending him. Alissa gave “superficial responses” to questions about hypothetical legal situations which indicate a “passive approach to his defense” and “potential overreliance on his attorneys," according to excerpts from the report included in the prosecution's motion last week for a second evaluation.

AstraZeneca said its experimental drug had helped cut the risk of severe disease or death in a late-stage study. * An AstraZeneca senior executive said the drugmaker's antibody cocktail would have a "real advantage" in preventing infection with the coronavirus compared with use as a treatment, after trials showed promise in both settings. * The European Union's drugs regulator is evaluating a marketing authorisation for an antibody cocktail developed by Roche and Regeneron for the treatment and prevention of COVID-19 in people above the age of 12.

GENEVA (Reuters) -The World Health Organization on Monday recommended that immunocompromised people be given an additional dose of COVID-19 vaccine, due to their higher risk of breakthrough infections after standard immunisation. The Strategic Advisory Group of Experts on immunisation said the additional dose should be offered "as part of an extended primary series since these individuals are less likely to respond adequately to vaccination following a standard primary vaccine series and are at high risk of severe COVID-19 disease". WHO vaccine director Kate O'Brien, referring to people with lower immunity due to other conditions, told a news briefing: "The recommendation is for a third vaccination, an additional vaccination in the primary series and again that is based on the evidence showing that the immunogenicity and evidence on breakthrough infections is highly disproportionately represented by those people."

The Johnston County school board amended its code of ethics to ban Critical Race Theory. Here’s why that’s remarkable. (Opinion)

Chinese state media said loopholes allowing minors to bypass new rules aimed at curbing gaming play time to three hours per week should be removed to "prevent addiction." China introduced new rules in August limiting the amount of time under-18s can spend on video games to three hours a week, a move it said was necessary to combat gaming addiction, but causing young Chinese gamers to express outrage at the rules.

Data: Quorum State; Cartogram: Kavya Beheraj/Axios There are twice as many states that have solid, Republican-controlled legislatures as those with solid, Democratic-controlled ones, according to Quorum's new 2021 State Legislative Trends Report.Why it matters: The power of state legislatures has been on national display in recent weeks, with Texas and other states passing voting and abortion restrictions, and coronavirus-related laws, as well as redrawing election district boundaries for the ne

Merck & Co said on Monday it has applied for U.S. emergency use authorization for its tablet to treat mild-to-moderate patients of COVID-19, putting it on course to become the first oral antiviral medication for the disease. Its authorization could help change clinical management of COVID-19 as the pill can be taken at home. AstraZeneca's experimental COVID-19 drug has helped cut the risk of severe disease or death in a late-stage study, the British drugmaker said on Monday, a boost to its efforts to develop coronavirus medicines beyond vaccines.

In an attempt to lay out the Biden administration’s approach to charting the course of the U.S.-China economic relationship, U.S. Trade Representative Katherine Tai underscored that the bilateral relationship is “complex and competitive.”

You don’t have to dish out tons of money to see results.

It’s Monday, Oct. 11, and do you know where Florida’s masks, quarantines and mandates are?

Essentials to soothe COVID-19 symptoms and keep your household protective, like disinfecting wipes, masks, humidifiers and more

More than 2,100 coronavirus-related hospitalizations were reported Monday.

The 'slap a teacher' TikTok challenge is being condemned by the social media platform and school districts across the nation.

Data: U.S. Bureau of Labor Statistics; Chart: Axios Visuals The silver lining in Friday’s mediocre jobs report was this milestone: The unemployment rate dropped below 5% for the first time since the pandemic sent workers home in droves. Yes, but: Part of what pushed it down was shrinking labor force participation. Stay on top of the latest market trends and economic insights with Axios Markets. Subscribe for freeBy the numbers: The labor force, which includes anyone who either has a job or is ac

Granville Adams, who played Zahir Arif on HBO's prison drama Oz, was remembered by former colleagues after he passed away at age 58 following a battle with cancer.

Research shows pandemic precautions, like wearing masks and social distancing, helped stop the spread of flu and other common respiratory viruses last season, but now those precautions aren't as prevalent.

New Zealand is fighting the highly infectious Delta outbreak that forced it to abandon its long-standing strategy of eliminating the new coronavirus amid persistent infections and is looking to live with the virus through higher vaccinations. "New Zealand is at one of the trickiest and most challenging moments in the COVID-19 pandemic so far," Ardern told reporters in Wellington. Ardern, however, said "there is a clear path forward" in the next few months to live with fewer curbs and more freedoms once the country reaches a higher level of vaccinations.

Business Stories