Pfizer said Tuesday that it is requesting authorization in the United States for its experimental antiviral pill for Covid-19, which reduced by 89% the possibility of hospitalization or death of adults at risk of serious illness in a clinical trial.
Pfizer stated that you completed the submission of your request for authorization of emergency use of the drug, Paxlovid, to Food and Drug Administration of the United States (FDA), including data from the pharmacist’s clinical trials.
The oral drug could be a promising new weapon in the fight against the pandemic, as it can be taken as an early treatment at home to help prevent hospitalizations and deaths from Covid-19.
Furthermore, it could become an important tool in countries and areas with limited access to vaccines or with low vaccination rates.
It is not clear when US regulators will comment on the request for Pfizer.
Merck and Ridgeback Biotherapeutics, which are developing a competing pill, the molnupiravir, completed their presentation for emergency use on October 11.
A group of outside FDA advisers will meet to study Merck’s application on November 30, and the drug is expected to be available this year.
“We are moving as quickly as possible in our effort to put this potential treatment in the hands of patients, and we look forward to working with the US FDA on their review of our application, along with other regulatory agencies around the world,” he said. Pfizer CEO Albert Bourla in a press release.
The New York-based drug maker said it has started the authorization application process in several countries, including the UK, Australia, New Zealand and South Korea, and plans to file more international applications.
Pfizer had said Tuesday that it would allow generic manufacturers to supply its Covid-19 pill in 95 low- and middle-income countries through a licensing agreement with the international public health group Medicines Patent Pool (MPP).
Reference-www.eleconomista.com.mx