Urgent approval of the experimental antiviral pill her for him coronavirus, which reduced by 89% the risk of hospitalization or death in adults in a clinical trial, the US Pfizer.
The company announced that it has completed the submission of its application to the Food and Drug Administration (FDA) to obtain the urgent approval for use (EUA) of the drug Paxlovid. Among other things, he submitted data from the clinical trial of the drug.
This pill may be a promising new weapon in the fight against pandemic after may administered at home, at the beginning of the disease, as a treatment that would help 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, APE reports.
It has not been clarified yet never Pfizer’s request will be considered.
It is noted that the companies Merck & Co Inc and Ridgeback Biotherapeutics, which develop a competitive formulation, the molnupiravir, completed their application on October 11. An FDA External Advisory Committee will meet to consider this request on November 30 and the decision is expected to be made within the year.
Burla: We are moving forward as fast as possible
“We are moving forward as quickly as possible in our efforts to bring 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,” he said in a press release. Albert Burla, the CEO of Pfizer.
The pharmaceutical industry has stated that it has started similar procedures for the approval of its drug in many other countries, such as United Kingdom, the Australia, τη New Zealand and South Korea.
Earlier today Pfizer announced that will allow generic drug companies to supply 95 low- and middle-income countries with its Covid-19 formulation.
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