Dec 22

Dec 22 FDA Clears First At-Home Covid-19 Treatment Pill

In A Historic Move And Under FDA Emergency Use Authorization, A Pill Is Added To The COVID-19 Treatment Toolbox To Help Prevent Severe Illness In High-Risk Populations

By Maria Lopez-Bernstein

For months, we’ve been hearing about a pill that can help prevent severe illness in COVID-19 patients and many have been waiting with patience and hope that the research proves its effectiveness and that it becomes approved this year.

The long-awaited milestone is over, just in time for the holidays.

The Food and Drug Administration on Wednesday authorized the first pill for COVID-19, under emergency use authorization (EUA) offering a highly effective defense against severe illness that may arrive within days as the country faces yet another major surge of the coronavirus pandemic that could overwhelm hospitals.

“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,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”

The drug called Paxlovid, developed by Pfizer, is authorized for COVID-19 patients age 12 and over, regardless of vaccination status, who are vulnerable to becoming severely ill due to their age or underlying health conditions, including diabetes and obesity.

In clinical trials, Paxlovid offered 88% reduction in hospitalizations and deaths among patients most likely to get severe disease when started within the first five days of symptoms. Side effects are considered mild.

A major plus is that Pfizer’s laboratory studies indicate that its pills are likely to work against the Omicron variant, which has rapidly become the dominant form of new cases of COVID-19 in the U.S., because it doesn’t target the spike protein where most of the variant’s worrisome mutations reside. Add to that the fact that Paxlovid is a faster, cheaper way to treat early COVID-19 infections, and it’s a game changer.

The at-home treatment that will be available by prescription consists of 30 pills taken over 5 days. Patients must have a positive COVID-19 test, be considered at higher risk for serious illness from a COVID infection, and take three pills at a time: two of Pfizer’s pills and one of a low-dose H.I.V. drug known as ritonavir, which helps Pfizer’s drug remain active in the body longer.

Though the pills are expected to become available within days, the initial supply will be very limited - about 60,000 to 70,000 allocated t o the U.S. - and will be rationed in the U.S. to areas in highest need until more can be produced. According to Pfizer, production takes nine months and therefore, release of medication will be in cycles. They will also make the treatment available outside the United States.

Merck’s antiviral pill Molnupiravir is also expected to win FDA approval soon. In a clinical trial, Merck’s drug reduced risk of hospitalization and death for high-risk patients by 30 percent, and had slightly higher side effects, making Paxlovid the preferred treatment.

Health officials at the FDA warn that Paxlovid is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19. Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.

Credit for main image: Artem Tryhub | Dreamstime.com