FDA OKs Pfizer Pill as First At-Home COVID Treatment


 FDA OKs Pfizer Pill as First At-Home COVID Treatment

(Black PR Wire) The U.S. Food and Drug Administration on
Wednesday, Dec. 22, approved the emergency use of Pfizer’s new
antiviral pill Paxlovid in people who are at high risk for severe
COVID-19. It’s the first approved treatment for COVID-19 meant
to be taken at home.

“Today’s authorization introduces the first treatment for
COVID-19 that is in the form of a pill that is taken orally — a
major step forward in the fight against this global pandemic,” Dr.
Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation
and Research, said in an agency news release. “This authorization
provides a new tool to combat COVID-19 at a crucial time in
the pandemic as new variants emerge.”

Pfizer first asked for emergency authorization in mid-November,
and later announced stunning final trial results on the power of
Paxlovid to guard against severe COVID-19. In that trial, the pill,
taken for five days, slashed a person’s odds for hospitalization and
death by nearly 90% in high-risk people. Paxlovid should be taken
within three to five days of symptom onset, the FDA said.

“Today’s authorization of Paxlovid represents another tremendous
example of how science will help us ultimately defeat
this pandemic, which, even two years in, continues to disrupt and
devastate lives across the world,” Pfizer Chairman and CEO Albert
Bourla said in a company statement. “This breakthrough therapy,
which has been shown to significantly reduce hospitalizations and
deaths and can be taken at home, will change the way we treat
COVID-19, and hopefully help reduce some of the significant
pressures facing our health care and hospital systems.”

How will an oral pill help?

“Paxlovid’s approval is a major milestone that marks another
step towards making COVID-19 a much more manageable infection,”
said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins
Center for Health Security, in Baltimore. “An oral pill that can cut
hospitalizations and deaths by 90% is pathbreaking. There are two
key issues, however, that remain: it will be scarce in the coming
weeks, and its optimal use requires prompt diagnosis, which can be
difficult with the continual testing problems that plague us.”

At the time of the trial results, Bourla stressed the importance
of adding another weapon to the COVID-fighting arsenal.

“This news provides further corroboration that our oral antiviral
candidate, if authorized or approved, could have a meaningful
impact on the lives of many, as the data further support the efficacy
of Paxlovid in reducing hospitalization and death, and show a
substantial decrease in viral load. This underscores the treatment
candidate’s potential to save the lives of patients around the world,”
Bourla said in a company statement released Dec. 14 with the
trial results. “Emerging variants of concern, like Omicron, have
exacerbated the need for accessible treatment options for those
who contract the virus, and we are confident that, if authorized or
approved, this potential treatment could be a critical tool to help
quell the pandemic.”

Does an oral pill work for people that are
low risk?

Pfizer also delivered some good news about people who are
at low risk for severe COVID-19 at that point: In an early anaylsis,
a second, ongoing study that tested whether Paxlovid eased
COVID-19 symptoms faster in people who are not considered
high-risk found no benefit for symptom relief.

But those who took the pill regimen saw the amount of virus
in their bodies plummet, and the pill reduced the already low risk
for hospitalization and death. That study included those who were
vaccinated and had at least one risk factor for severe COVID-19.

Side effects of Paxlovid

Paxlovid is a combination of a new molecule developed
specifically to disable SARS-CoV-2 and ritonavir, an HIV medication
that helps slow the breakdown of the coronavirus-specific
molecule.

The drug does have some limitations. Ritonavir can interact
with many commonly taken medicines, and those risks may need to
be managed by physicians and pharmacists, the FDA said.

Possible side effects of Paxlovid include impaired sense of
taste, diarrhea, high blood pressure and muscle aches, the FDA said.
Using Paxlovid in people with uncontrolled or undiagnosed HIV
infection may trigger HIV-1 drug resistance. Ritonavir can cause
liver damage, so caution should be used when giving Paxlovid to
patients with liver conditions, the agency added.

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