FDA Authorizes First Take-Home Pill To Treat COVID-19 In MA

MASSACHUSETTS — The US Food and Drug Administration authorized the first antiviral pill to treat COVID-19 on Wednesday.

Pfizer's pill, Paxlovid is approved for ill patients in Massachusetts and the rest of the country to take at home before they become sick enough to be hospitalized. Individuals who are high-risk, aged 12 and older, and have a positive SARS-CoV-2 test are eligible for this treatment and will need to have it prescribed by a doctor.

The pill "should be initiated as soon as possible after diagnosis of Covid-19 and within five days of symptom onset," according to the FDA.

More coverage: When Will COVID-19 Pills Be Available In Massachusetts?

Gov. Charlie Baker announced a rapid testing initiative for the state last week, promising about 2.1 million at-home testing kits that will be going out to 102 communities across the state in an attempt to help those who have been hit hardest by the coronavirus.

Paxlovid combines a new antiviral drug named nirmatrelvir and an older one called ritonavir and is administered as three pills given twice a day for five days.

The FDA is also preparing to make decisions on a second COVID-19 pill coming from Merck & Co., as the two were set to be approved by the end of the month.

Now that Paxlovid has been approved, Massachusetts doctors can immediately order pills from medical distributors for their patients to pick up. The federal government says they will put caps on the number of pills physicians can order for their patients at first.

This approval comes just as coronavirus cases surge through Massachusetts, with the Omicron variant creeping in on the Christmas season, prompting a spike in hospitalizations and knocking hospital intensive care units close to capacity.

In Pfizer's studies, adults taking the company's drug had a 10-fold decrease in virus levels compared with those on placebo — enough to possibly keep patients out of the hospital.

President Joe Biden called Paxlovid a "potentially powerful tool in our fight against the virus, including the Omicron variant," but stressed that getting vaccinated and receiving a booster shot remained "the most important tools we have to save lives."

Patients will have to take 30 to 40 pills in a five-day period, and they will need to begin treatment within three days after they are infected.

More coverage: COVID-19 Booster Shots: Where To Find Them In Massachusetts

Health experts worry high-risk patients infected with COVID-10 may not be able to get tested and treated in that three-day timeframe. Studies of a similar drug used to limit the impact of influenza show that only 40 percent of high-risk patients got diagnosed within the three-day window to begin treatment.

Remdesivir, sold under the brand name Veklury, was the only antiviral approved by the FDA for treatment of Covid-19 prior to Paxlovid. It's given intravenously, and not as a pill that can be taken at home.

More on Patch

• COVID Tests In MA Are In Short Supply: Here's How To Get One
• When Will COVID-19 Pills Be Available In Massachusetts?
• COVID-19 Booster Shots: Where To Find Them In Massachusetts
• Critical ICU Bed Shortage At UMass Memorial: Report
• More Beverly Coronavirus Rapid Tests Available Thursday