For healthier patients, Pfizer's Covid pill was proven to be useless
Key Takeaways:
- Pfizer Inc. plans to halt enrollment in a study of its Covid-19 drug in patients who aren't at high risk of serious disease, a significant setback for the treatment's widespread use.
- This month, Pfizer disclosed fresh Paxlovid study on clinicaltrials.gov, which will evaluate the drug's safety and tolerability in a small group of pregnant women in the second or third trimester.
After the pill failed to relieve their symptoms, Pfizer Inc. plans to suspend enrolling patients in a study of its Covid-19 medicine in patients who aren't at high risk of severe disease, a major setback for the treatment's wider usage.
The New York-based pharmaceutical company announced on Tuesday that it would suspend enrolling new patients in a highly anticipated research that will test Paxlovid in a larger group of Covid patients at low risk of hospitalization and death.
The decision was made after the study failed to establish that the medicine reduced Covid symptoms in otherwise healthy people, as well as a statistically significant decrease in hospitalization and death.
Pfizer's stock slipped 0.1 percent in New York postmarket trade. The findings are the latest setback for the company's plans to grow the market for its blockbuster Covid tablet. Paxlovid was found to be ineffective as a prophylactic measure for persons who had been exposed to the virus, according to a study published in late April.
"The study demonstrates the difficulty of showing a benefit of antiviral therapy in previously immunized or otherwise low-risk individuals," said Paul Sax, clinical director of Brigham as well as Women's Hospital in Boston's Division of Infectious Diseases.
The study looked at Covid-positive patients who were either unvaccinated or had been fully vaccinated but had at least one medical condition that put them at risk for serious illness.
According to the company, the study's findings aren't likely to influence Pfizer's full-year revenue forecast. For the Covid tablet, the pharmaceutical has already secured $22 billion in contracts until 2022.
The pharmaceutical company stated that it would concentrate its efforts on testing the medicine in vulnerable populations, such as immunocompromised or currently in the hospital.
"With up to 40-50 percent of people around the world estimated to be at high risk," said Chief Executive Officer Albert Bourla in a statement, "we believe there remains a substantial unmet need for treatment options that help combat this disease, and we will continue to prioritize efforts to advance the development of Paxlovid."
Pfizer announced new Paxlovid research on clinicaltrials.gov this month, which would assess the drug's safety and tolerability in a small group of pregnant women in their second or third trimester. Paxlovid is also being studied in children, and a trial in adults with impaired immune systems will begin soon.
Pfizer released preliminary findings from the research in December, suggesting that Paxlovid failed to relieve symptoms in so-called "standard risk" patients and did not reduce the risk of hospitalization or death statistically.
The latest findings demonstrate that the trial failed to reach its primary goal of self-reported relief of all symptoms for four days. Given the small number of outcomes in the trial, a secondary evaluation of reducing the risk of hospitalization or death was not statistically significant.
In the United States, Paxlovid has an emergency-use license to treat high-risk patients with Covid. This is a provisional regulatory classification that can be revoked at any time.
As part of Pfizer's proposal for full approval of the medicine, the results of the trial of standard-risk Covid patients would be submitted to the Food and Drug Administration.