Pfizer to seek authorization of COVID-19 pill ‘as soon as possible’

Americans may soon have a choice in COVID-19 pills that they can take at home

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Pfizer’s experimental COVID-19 antiviral can cut the risk of ending up in the hospital or dying by 89%, and this means that Americans may soon have a choice in COVID-19 pills that they can take at home.

The news sent shares of Pfizer PFE, -0.65% soaring 8.2% in trading on Friday, capping off a week in which the company reported better-than-expected sales of its COVID-19 vaccine and shared that its oral COVID-19 pill had compelling results in a clinical trial. 

“As long as you have COVID around, you will have a need to vaccinate and protect, and then you will have a need to treat and save lives,” Pfizer CEO Albert Bourla told investors during Tuesday’s earnings call, according to a FactSet transcript.

Merck & Co. Inc. MRK, -5.13% is also developing a COVID-19 antiviral, which is currently under review at the Food and Drug Administration. Its shares tumbled 8.5% on Friday after Pfizer shared the first late-stage clinical data for its drug, Paxlovid.

If either or both of the antivirals are authorized in the coming months—Merck’s drug is set to be reviewed by a FDA advisory committee on Nov. 30—it will change how we care for people who are sickened with COVID-19.

Prescribing pills to people at home means those who have medical conditions that put them at high risk of severe COVID-19 don’t need to go to clinics to receive infusions, as is necessary for the monoclonal antibodies. It also means that fewer people who get severely ill could end up in the hospital or die. 

“Paxlovid will be a game-changer for the course of the pandemic and should accelerate our return towards our pre-COVID normalcy,” RBC Capital Markets analyst Brian Abrahams told investors on Friday. 

Merck kicked off the wave of antiviral interest in early October when the company announced that the COVID-19 pill it’s developing with the privately held Ridgeback Biotherapeutics can reduce the risk of hospitalization and death by 50% among adults who are at high risk of severe disease.  

This is the first pill to demonstrate it can keep severe illness caused by the virus at bay, and the U.K. on Thursday became the first country to authorize molnupiravir. 

Wall Street analysts say that the data for Pfizer’s drug indicates that it may work better than the Merck pill, and that Paxlovid’s compelling figures are good for most of the COVID-19 antivirals in development. (Enanta Pharmaceuticals Inc.’s ENTA, -9.00% stock was up 13.1% on Friday, while shares of Atea Pharmaceuticals Inc. AVIR, -3.69% slid 8.8%.)

“It provides more confidence in oral antivirals having a meaningful impact on treating COVID-19,” SVB Leerink’s Roanna Ruiz told investors. “It shows multiple mechanisms can work against COVID-19, and it provides insights on what trial designs are optimal for finding an antiviral efficacy signal in COVID-19 patients.”

If authorized, these therapies will also set up new revenue streams for both companies. Analysts are already predicting between $5 billion and $7 billion in sales of Merck’s antiviral next year.

“At this point, we believe governments will buy both Merck and Pfizer treatments in similar quantities since they have different resistance profiles and other characteristics,” Morgan Stanley analysts wrote in an investor note.

Pfizer’s randomized, double-blind Phase 2/3 clinical trial tested Paxlovid in 1,219 unvaccinated adults with COVID-19 who were at high risk of severe disease. Less than 1% of the patients who took the drug were hospitalized by the 28-day mark, compared with the 7% who received the placebo and were hospitalized or died. Participants took two pills a day for five days.

The clinical data was shared in a news release; the research has not yet been published in preprint form or as a peer-reviewed study.

The drug maker said it plans to apply for emergency-use authorization “as soon as possible.”

Pfizer’s stock has rallied 19.3% so far this year, while the broader S&P 500 SPX, +1.36% has gained 24.6%.

Read more eLesor coverage of COVID-19 treatments:

Merck’s COVID-19 pill could bring in up to $7 billion in sales next year

The success of Merck’s antiviral—and other COVID-19 pills in development—may depend on how quickly people start taking them

Why a pill you take at home could change the direction of the pandemic