Merck Covid drug does not reduce risk of hospitalization, study says

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Merck’s Covid-19 antiviral pill has failed to demonstrate effectiveness in reducing the risk of hospitalization and death among adults at highest risk of the disease, according to the results of a major clinical trial in the UK.

Preliminary results published Thursday from a trial of more than 25,000 people show that taking molnupiravir – a key treatment for Covid – can speed up a patient’s recovery time. But the drug showed no benefit over placebo in terms of reducing hospitalizations, one of the key measures used by regulatory authorities to recommend antiviral treatments.

Chris Butler, a professor of primary care at the University of Oxford and the study’s lead investigator, did not go so far as to call it a failure, but said there was “no difference” between receiving the drug or a placebo in a context of low hospitalizations during pregnancy. wave of the omicron strain of Covid-19.

Omicron was shown to be less severe than variants that circulated previously. Butler stressed that the results are preliminary and that further analysis would allow regulators to make decisions about how to use the drug.

Some health experts said the results would cast further doubt on molnupiravir’s effectiveness. The treatment has generated nearly $5 billion in sales, but critics claim it has yet to demonstrate that it offers a clear benefit to patients or economics.

Merck’s drug, which is branded Lagevrio, raised hopes and sent the company’s stock higher last year after initial data from a late-stage trial suggested it halved the risk of death and hospitalization. But further analysis revealed that its effectiveness was lower than previously thought, just 30%.

Andrew Hill, a senior visiting researcher at the University of Liverpool, said the fact that it failed to meet its target of reducing hospitalizations or deaths raised questions, particularly as the UK study is the largest ever conducted of a treatment for Covid-19.

“If molnupiravir does not show any benefit, it will be difficult for health officials to justify the $5.5 billion spent on the drug worldwide so far,” he said.

“We’ve seen this situation before with other Covid-19 drugs such as remdesivir. Early results looked encouraging, but larger trials showed no benefit.”

The UK trial was cited as a key piece of evidence for the approval of molnupiravir in the European Union. But the bloc’s regulatory agency, the European Medicines Agency (EMA), has delayed its review due to concerns about effectiveness, the Financial Times reported earlier this year.

A person close to the regulator said it was difficult to assess whether the drug had any significant effects. “Unfortunately, it is difficult to say much about molnupiravir, other than that it does not appear to affect progression. [da doença].”

The EMA has not yet approved it.

The UK regulator, Medicines and Healthcare Products Regulatory Agency, has approved the drug on limited terms. The US Food and Drug Administration has approved molnupiravir but has restricted its use. Most regulators said it should be used as a second or third option for treating the disease.

Merck said the trial produced important results and provided support for Lagevrio’s value in this evolving pandemic, where vaccination rates are higher and the omicron variant is causing less serious illness, including fewer hospitalizations and deaths.

Originally translated from English by Luiz Roberto M. Gonçalves

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