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Pfizer halts COVID drug Paxlovid trial for standard-risk population
The new data, however, showed a 51% relative risk reduction in standard-risk groups, which the company said was not statistically significant.
New Delhi: Pfizer Inc said on Tuesday it would halt enrollment in a trial for its COVID-19 antiviral drug, Paxlovid, in standard-risk patients after a study revealed the treatment was not effective in reducing symptoms in that group.
The drug has emergency use authorization for high-risk groups in which it has been effective in reducing hospitalizations and deaths.
The new data, however, showed a 51% relative risk reduction in standard-risk groups, which the company said was not statistically significant.
The standard-risk population usually includes people who do not have health conditions that put them at risk of severe disease and who can recover without the drug.
Pfizer said it will include the new data in the company's upcoming application to the U.S. Food and Drug Administration seeking full approval for the drug's use in high-risk groups.
Read also: Generic drugmakers to sell Pfizer COVID drug Paxlovid for USD 25 or less in low-income countries
Data from a study in Israel earlier this month showed the drug reduces COVID-19 hospitalization and death rates in vaccinated and unvaccinated patients 65 years and older, but was not found to prevent severe illness among younger adults.
More than 1.2 million courses of Paxlovid have been administered in the United States, according to data from the Assistant Secretary for Preparedness and Response under the U.S. Department of Health & Human Services.
Read also: Study says Pfizer COVID drug Paxlovid reduces COVID risk in seniors regardless of vaccine status
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751