Pfizer submits FDA software for emergency approval of Covid therapy capsule

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 says its Covid tablet with HIV drug cuts the chance of hospitalization or dying by 89%

Pfizer said Friday that its easy-to-use Covid-19 pill, used in combination with a widely used HIV drug, increased the risk of hospitalization or death in high-risk adults exposed to the virus by 89% lowers.

It’s now the second antiviral pill behind it Merck‘s to demonstrate strong efficacy in treating Covid at the first sign of disease. If approved by regulators, it would likely mark a turning point in the ongoing global battle against the pandemic.

Pfizer CEO Albert Bourla told CNBC the company plans to submit its data to the Food and Drug Administration before Thanksgiving.

“I think this drug is going to change the way things are happening, that are going to save millions and millions of lives, it has the potential to do that,” Bourla said in an interview with CNBC.Squawk box“He said the company has” the current capacity of 500 million pills, “which in his opinion equates to 50 million treatments.” The very high level of effectiveness comes as a surprise even to us and exceeds our most visionary expectations about it. “

Pfizer’s pill, scientifically known as PF-07321332, belongs to a class of drugs called protease inhibitors and works by blocking an enzyme that the virus needs to multiply in human cells. Protease inhibitors are used to treat other viral pathogens such as HIV and hepatitis C.

The HIV drug helps slow the metabolism or breakdown of the Pfizer pill so that it stays active in the body for longer periods of time at higher concentrations, the company said.

The company said its data on the drug is based on a mid-to late-stage study of 1,219 adults who had at least one underlying disease and one laboratory-confirmed infection within five days. Participants also received a low dose of ritonavir, a drug often used in combination treatments for HIV.

Pfizer said there were six hospitalizations and zero deaths of the 607 study participants who received the pill in combination with the HIV drug within five days of the onset of symptoms. That compares to 41 hospitalizations and 10 deaths for the 612 people who received a placebo.

“These data suggest that our oral antiviral candidate, if approved by regulators, has the potential to save patients’ lives, reduce the severity of COVID-19 infections and achieve up to nine out of ten hospital stays Avoid, “said Albert Bourla, CEO of Pfizer in a statement.

not how Gilead SciencesThe intravenous drug Remdesivir, Pfizer and Merck drugs can be taken orally. While vaccinations remain the best form of protection against the virus, health experts hope pills like these will prevent the progression of the disease in those who become infected and prevent hospitalizations.

Biotherapeutics from Merck and Ridgeback said on October 1st that they developed a drug that, when given on its own, reduces the risk of hospitalization or death in patients with mild or moderate cases of Covid by about 50%.

Merck’s antiviral pill was approved by The UK Medicines Agency on Thursday.

June Raine, chief executive of the UK’s drug and health products regulator, said the Merck pill is the treatment of Covid, a disease that has cost the lives of more than 5 million people worldwide and has put an enormous strain on health systems.

Bourla told CNBC in April that Pfizer’s pill could be available to Americans by the end of this year.

Dr. Scott Gottlieb says Merck’s Covid capsule ‘could make an actual distinction’

DR. Scott Gottlieb explained why he is so optimistic Merck‘S Covid antiviral pill after drug maker asked Food and Drug Administration on Monday to approve his pill to treat people with mild to moderate symptoms of Covid.

“The topline data from this Merck study were probably the best treatment effects we’ve seen with oral antiviral drugs in the treatment of respiratory pathogens.

If the agency picks up the drug, it will be the first pill proven to work against Covid-19, and Americans could get it by the end of the year.

Gottlieb told CNBCs “The News with Shepard Smith” The Merck pill is part of an “overall, significant improvement in our therapeutic toolkit against this virus, not just with vaccines and therapeutics, but with more accessible diagnostic tests.”

Host Shepard Smith also asked Gottlieb about masking rules across the country. Gottlieb told Smith that he believes decisions are made locally, noting the uneven prevalence of the Delta variant in the US

“We’ve seen sharp declines in the south, where most of the delta runs, so cases are falling very sharply in populous states like Texas and Florida, but you’re seeing pretty dense epidemics in the Midwest and the simple states, and we me I still don’t know how the Northeast and the Northern States will fare, “said Gottlieb.

He predicted that a Covid-19 delta wave could hit the northern US states despite higher vaccination rates and higher previous infection rates.

“I still think there is a delta wave that will sweep across the northern states, including the northeast,” said Gottlieb.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion Inc., and biotechnology company Illumina. He is also co-chair of the Healthy Sail Panel of Norwegian Cruise Line Holdings and Royal Caribbean.