Pfizer seeks authorization to use anti-Covid drug in US

Pfizer said on Tuesday (16) that it has completed the request for authorization in the United States for the emergency use of its anti-Covid pill, paxlovid.

The clinical trial that showed how the drug reduces by 89% the chance of hospitalization or death of adults who are at risk of developing the severe form of the disease was also delivered.

It is not yet known when the FDA (the US drug approval agency) will decide on Pfizer’s request. Merck (known as MSD in Brazil) and Ridgeback Biotherapeutics, which are developing a competing pill, molnupiravir, completed the US submission on Oct. 11.

A panel of outside FDA advisors will meet to consider this request on Nov. 30, and the drug is expected to be available later this year.

“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients and look forward to working with the US FDA to review our application, along with other regulatory agencies around the world,” Albert Bourla said in a statement. , chief executive of the pharmaceutical company.

Pfizer’s treatment, in combination with ritonavir, consists of three pills given in two daily doses. The company plans to produce more than 180,000 doses by next month and another 50 million, at least, by the end of 2022.

The New York-based drugmaker said it has started the process of obtaining authorization in several countries, including the UK, Australia, New Zealand and South Korea, and is planning new international submissions.

On Tuesday, Pfizer said it will allow generic manufacturers to supply their anti-Covid pill to 95 low- and middle-income countries through a licensing agreement with the international public health group Medicines Patent Pool (MPP).

Among the beneficiaries of the agreement are Bolivia, El Salvador, Haiti, India, Indonesia, Nigeria and Venezuela. Brazil is not on the list.