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Merck headquarters in New Jersey
Photo: Christopher Occhicone / Bloomberg via Getty Images
The corona drug Molnupiravir from the manufacturer Merck & Co is about to be approved in the USA.
An advisory group to the US FDA has spoken out in favor of emergency approval after hours of debate.
The vote is not binding, but the authority usually follows the vote.
The antiviral drug reduces the ability of the coronavirus to multiply in the body's cells and thus slows down the further development of Covid-19.
Emergency approval from the FDA could now follow within a few days.
A few weeks ago, Merck announced that, according to a clinical study, the drug administered as a tablet significantly reduced the likelihood of very severe disease in high-risk patients.
But it doesn't work as well as originally hoped.
In the study, corona patients with mild to moderate symptoms who were treated with a placebo had to go to hospital within 29 days in 14.1 percent of the cases or died.
In the group of patients who were treated with the drug named molnupiravir, 7.3 percent were only about half as many.
The numbers are based on an evaluation of the data from 775 corona patients.
All subjects had at least one risk factor that makes a severe course likely.
In the test group that received the Merck drug, there were no deaths during the study period, the company said.
In contrast, eight people who received the placebo died.
Already approved in Great Britain
Molnupiravir was the first country in the world to be approved in the UK in early November.
The EU Medicines Agency (EMA) is currently examining approval.
The US pharmaceutical giant Pfizer has developed a similar agent.
At the beginning of November, Pfizer announced the effectiveness of its drug Paxlovid with 89 percent.
The pills have the advantage of being easy to take at home.
On the other hand, other drugs, such as the antiviral drug Remdesivir, must be administered intravenously.
The US government announced a bulk order for ten million packs of the Pfizer drug for $ 5.3 billion.
The order was placed subject to FDA approval.
Paxlovid is taken orally and has an antiviral effect.
As a protease inhibitor, it inhibits the activity of protein-splitting enzymes - in this case it specifically inhibits the multiplication of Sars-CoV-2 in the body.
According to the company, the interim analysis included data from 1219 people from different countries who are part of a phase II / III study that has been ongoing for a few weeks.
No deaths among study participants
0.8 percent of people who were treated with paxlovid in the first three days of onset of symptoms had to be hospitalized within the next 28 days, Pfizer reported. In the group of participants who had received a placebo, it was seven percent. There were no deaths in the paxlovid group, while seven people died in the placebo group.
There were similarly good results when the patients were treated for up to five days after the onset of symptoms.
Here, one percent of the paxlovid group was hospitalized within the next 28 days and no one died.
Among the participants who received a placebo, 6.7 percent had to be treated in the hospital within 28 days and ten people died.
fww / dpa
