Pfizer announced on Tuesday that it had asked the US authorities for urgent approval of its experimental coronavirus antiviral pill, which reduced the risk of hospitalization or death in adults by 89% in a clinical trial.
Pfizer said it had completed its application to the Food and Drug Administration (FDA) for obtaining the EUA Urgent Use Approval (PAC). Among other things, he submitted data from the clinical trial of the drug.
It is administered at the beginning of the disease
This pill may be one promising new weapon in the fight against pandemic since it can be administered at home, at the beginning of the illness, as a treatment that would help to avoid hospitalization and death. It could also become an important tool in countries and regions with limited access to vaccines or with low vaccination rates.
It is not yet clear when Pfizer's request will be considered. THEMerck & Co Inc and Ridgeback Biotherapeutics, which are developing a competing drug, molnupiravir, completed their application on October 11. An FDA external advisory committee will meet to consider this request on November 30, and a decision is expected within a year.
Procedures for approval in other countries as well
"We are moving forward as quickly as possible in bringing this potential treatment to patients and look forward to working with the FDA to review our application, as well as with other regulators around the world," Albert Burla told a news conference. , the CEO of Pfizer.
The pharmaceutical industry has said it has begun similar procedures for approving its drug in many other countries, including the United Kingdom, Australia, New Zealand and South Korea. Earlier today, Pfizer announced that it would allow manufacturers of generic drugs to supply its Covid-19 95 low- and middle-income countries.