Tag: submits

Pfizer submits FDA software for emergency approval of Covid therapy capsule

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Albert Bourla, CEO of Pfizer, speaks to a press conference after a visit to monitor the production of the Pfizer-BioNtech COVID-19 vaccine at the US pharmaceutical company Pfizer’s factory in Puurs, Belgium, on April 23, 2021.

John Thys | Swimming pool | Reuters

Pfizer filed an application with the Food and Drug Administration on Tuesday for emergency approval of its Covid-19 treatment pill, saying it reduces hospital stays and deaths by 89% when given with a popular HIV drug.

The pill, if approved by the FDA, could help revolutionize the fight against Covid by allowing high-risk people infected with the virus to take an oral antiviral drug at home instead of going to the hospital. Such treatment could help ease the burden on hospital systems during the pandemic.

In a clinical study of people aged 18 and over who were at increased risk of developing severe Covid, the pill reduced hospital stays and deaths by 89% when taken within three days of symptoms appearing. according to Pfizer.

The pill, known as paxlovid, blocks the activity of an enzyme that the virus needs to replicate. Paxlovid is used in combination with a low-dose ritonavir, an HIV drug, to slow the patient’s metabolism down so that the drug can stay active in the body at a higher concentration for longer to fight the virus.

Pfizer said the Covid treatment was shown to be safe, adding that study participants taking paxlovid reported fewer adverse events than the placebo, and most of them were “mild intensity”.

If approved, paxlovid is given in two 150 mg tablets with one 100 mg tablet of ritonavir twice a day.

“We are working hard to get this potential treatment into patients’ hands as soon as possible and look forward to working with the US FDA to review our application as well as other regulatory agencies around the world,” said Pfizer Das said CEO Albert Bourla in a statement on Tuesday.

Bourla had previously said that Pfizer planned to file its data with the FDA before Thanksgiving.

Early Tuesday, Pfizer announced that it would allow generic drug companies to ship their antiviral pill to 95 low and middle income countries.

Merck is also developing an antiviral pill, molnupiravir, to fight Covid. The company found in an interim analysis that the pill reduced the risk of hospitalization and death in adults with mild to moderate Covid by 50%.

Merck, which co-developed the drug with Ridgeback Biotherapeutics, filed an application with the FDA for approval of the pill last month.

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Pfizer submits information to FDA for approval

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Walgreens health professional Luis S. Solano prepares a dose of Pfizer BioNTec’s vaccine against coronavirus disease (COVID-19) on February 22, 2021 at the Victor Walchirk Apartments in Evanston, Illinois.

Kamil Krzaczynski | Reuters

Pfizer and BioNTech announced on Monday that they had submitted early-stage clinical trial data to the Food and Drug Administration as part of their U.S. filing to approve a Covid vaccine booster for all 16 and older – not just people with weak immune systems.

In a phase 1 study, a booster dose of the vaccine produced “significantly higher neutralizing antibodies” against the original coronavirus strain and the beta and delta variants, the companies said in a press release. Study participants received a third dose of the two-dose vaccine around eight to nine months after the second vaccination, they said.

“The data we’ve seen so far suggest that a third dose of our vaccine elicits antibody levels well in excess of those on the primary two-dose schedule,” said Albert Bourla, Pfizer CEO. “We are excited to provide this data to the FDA as we continue to work together to address the evolving challenges of this pandemic.”

The companies said the results of the late-stage trial evaluating the third dose are expected shortly and will also be presented to the FDA and other regulatory agencies worldwide.

The announcement by the drug manufacturer comes according to federal health officials Friday approved Giving Covid booster shots of Pfizer and Moderna vaccines to Americans with compromised immune systems, including cancer and HIV patients, and people who have had organ transplants.

New data from the US suggests that immunocompromised individuals do not generate adequate immune responses after receiving two doses of a Covid vaccine.

The latest data from Pfizer investigates the booster’s safety and immune response in people with otherwise healthy immune systems.

Federal health officials are not currently recommending booster doses for the general public, but Dr. White House Chief Media Officer Anthony Fauci said: Everyone is “likely” to need a booster at some point.

Covid vaccine manufacturers including Pfizer and Modern, have repeatedly argued that everyone will need a booster dose at some point and possibly additional doses each year, just like seasonal flu.

Pfizer has cited data from Israel where state officials said last month the two-dose vaccine was only 39% effective against the disease, which attributed the drop in performance to the highly contagious Delta variant. When Pfizer submitted its original application to the FDA in December, it said its vaccinations were about 95% effective at preventing Covid infections.

The vaccine is still considered highly effective against serious illness, hospital admissions and deaths, according to Israeli health officials.