Molnupiravir, an experimental drug for severe Covid developed by Merck, cuts the risk of hospitalization or death by about half, interim clinical trial results suggest.
The tablet was given twice a day to patients recently diagnosed with the disease.
Merck said its results were so positive that outside monitors had asked to stop the trial early.
The drug-maker said it would apply for emergency use authorization for the drug in the US in the next two weeks.
Dr Anthony Fauci, chief medical adviser to President Joe Biden, said the results were “very good news”, but urged caution until theFood and Drug Administration (FDA) had reviewed the data.
If authorized by regulators, molnupiravir would be the first oral antiviral medication for Covid-19.
Molnupiravir, which was originally developed to treat influenza, is designed to introduce errors into the genetic code of the virus, preventing it from spreading in the body.
An analysis of 775 patients in the study found:
7.3% of those given molnupiravir were hospitalized
that compares with 14.1% of patients who were given a placebo or dummy pill
there were no deaths in the molnupiravir group, but eight patients who were given a placebo in the trial later died of Covid
The data was published in a press release and has not yet been peer-reviewed.
Unlike most Covid vaccines, which target the spike protein on the outside of the virus, the treatment works by targeting an enzyme the virus uses to make copies of itself.
Merck said that should make it equally effective against new variants of the virus as it evolves in the future.
Trial results suggest molnupiravir needs to be taken early after symptoms develop to have an effect. An earlier study in patients who had already been hospitalized with severe Covid was halted after disappointing results.
Merck is the first company to report trial results of a pill to treat Covid, but other companies are working on similar treatments. Its US rival Pfizer has recently started late-stage trials of two different antiviral tablets, while Swiss company Roche is working on a similar medication.
The company has said it expects to produce 10 million courses of molnupiravir by the end of 2021. The US government has already agreed to buy $1.2 billion worth of the drug if it receives approval from the regulatory body, the FDA.
Merck said it is in ongoing discussion with other countries and has also agreed licensing deals with a number of generic manufacturers to supply the treatment to low and middle-income countries.
President Donald Trump has called on pharmaceutical companies to lower huge drug prices.
During a White House meeting with senior pharmaceutical executives President Trump told the companies to manufacture more of their drugs in the US.
However, the president also vowed to help the companies by speeding the approval of new medicines and by cutting taxes.
Donald Trump’s pledges helped to send shares in many of the biggest US drugmakers higher on January 31.
Pharmaceutical companies have faced intense criticism from US politicians – including Donald Trump – as well as insurance companies and patients’ groups over the high cost of new medicines and price hikes in some older generic drugs.
Image source Flickr
Among those attending the meeting were executives from Merck, Johnson & Johnson, Novartis, Amgen and the head of the Pharmaceutical Research and Manufacturers of America (PhRMA) lobbying group.
Donald Trump told them in the meeting: “US drug companies have produced extraordinary results for our country but the pricing has been astronomical for our country, we have to do better.
“We have to get even better innovation, and I want you to move your companies back to the United States.”
To help the drugmakers, Donald Trump said his administration was “going to be lowering taxes big league”.
“We’re going to be getting rid of regulations that are unnecessary – big league,” he added.
Donald Trump’s promise to speed up approvals by the FDA for new medicines sparked strong gains in pharmaceutical shares.
Shares in Merck and Amgen rose by about 1% while Novartis was up more than 2% on Wall Street.
The NASDAQ Biotech Index gained nearly 3% after the meeting and the S&P 500 health care index rose 1.4%.
Investors had sold off shares in drugmakers in recent weeks following heavy criticism from Donald Trump – supported by Democratic Senator Bernie Sanders – over drug pricing.
However, senior pharmaceutical executives welcomed Donald Trump’s proposals on January 31 to cut taxes and loosen regulations.
Gavi, the Vaccine Alliance, has signed a $5 million deal for an Ebola vaccine, to protect against future outbreaks of the deadly disease.
The deal commits pharmaceutical company Merck to keeping 300,000 vaccines ready for emergency use or further clinical trials.
It will also submit an application to license the vaccine by the end of 2017, which would the next step towards enabling Gavi to prepare a global stockpile.
More than 11,000 people have died in the latest Ebola outbreak in West Africa.
The sheer scale of the outbreak – the largest in history – led to an unprecedented push on vaccines, which condensed a decade’s work into less than a year.
Merck has led trials of the VSV-EBOV vaccine – which combines a fragment of the Ebola virus with another safer virus in order to train the immune system to beat Ebola.
Early evidence from studies in West Africa suggest it may give 100% protection, although more data is still being collected.
Gavi CEO Dr. Seth Berkley said: “The suffering caused by the Ebola crisis was a wake-up call to many in the global health community.
“New threats require smart solutions, and our innovative financing agreement with Merck will ensure that we are ahead of the curve for future Ebola outbreaks.”
Gavi is an alliance of public bodies and companies committed to saving lives through vaccination.
It announced the advanced-purchase commitment at the World Economic Forum held at Davos in the Swiss Alps.
The $5 million paid to Merck will be offset against any vaccines Gavi orders once the shot is licensed.
The World Health Organization declared West Africa Ebola-free last week, after all of the affected countries had gone 42 days without a case.
However, just hours later, a death in Sierra Leone was confirmed to be from Ebola.
Bayer has agreed to pay $14.2 billion to buy rival Merck’s consumer care business.
The German pharmaceutical company said buying the division, which makes Coppertone sun care products, Dr. Scholl’s foot health and allergy brand Claritin, was “a major milestone”.
Bayer said Merck would separately pay it $1 billion in a co-development deal over heart failure drugs.
Merck’s consumer care division makes Coppertone sun care products, Dr. Scholl’s foot health and allergy brand Claritin
It said the deal would help it develop sales outside the US.
Bayer also expects to become the second largest player in non-prescription, over-the-counter (OTC) products as a result of the acquisition.
“With this transaction, we are acquiring leading product brands,” said Bayer HealthCare boss Olivier Brandicourt.
Bayer said it expected the integration of the two businesses to generate significant cost savings of around $200 million per year by 2017.
Bayer also said increasing its commercial presence and rolling out Merck’s brands globally would amount to an additional $400 million in revenues per year by 2017.
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