The Food and Drug Administration (FDA) has approved a new drug for people to take after they are exposed to COVID-19.
The FDA approved Xocova, a pill also known as ensitrelvir, on May 29, according to the FDA website. The approval is for post-exposure prophylaxis following COVID-19 exposure.
Labeling and other information have not yet been released.
Shionogi, the Japan-based company that makes Xovoca, said in a June 1 statement that the approval is for post-exposure prophylaxis in children and adults aged 12 years and older.
The treatment regimen is five days. Three tablets are taken on the first day. For the other four days, one tablet per day is taken.
“Xocova is the first and only oral option clinically proven to help prevent symptomatic COVID-19 after exposure among study participants regardless of vaccination status or baseline immunity from prior infection,” Nathan McCutcheon, president and CEO of Shionogi’s U.S subsidiary, said in a statement. “With Xocova, people who are exposed to COVID-19 can act early to help protect themselves.”
Ensitrelvir was previously approved in Japan.
Shionogi stated that the approval was based, in part, on a phase 3 randomized, double-blind, placebo-controlled trial that found only 2.9 percent of people who received ensitrelvir following exposure to others infected with COVID-19 contracted the illness, compared to 9 percent of placebo recipients.
The trial results, published in May, covered about 2,000 people, virtually all of whom had antibodies against COVID-19 or spike protein, indicating that they had previously been infected with COVID-19 or received a COVID-19 vaccine. Shionogi funded the trial.
Dr. Frederick Hayden, an emeritus professor at the University of Virginia School of Medicine who worked on the trial, said in a June 1 statement that “ensitrelvir inhibits viral replication, helping protect people who have been exposed to COVID-19 from developing illness.”
He also said the post-exposure prophylaxis strategy “has the potential to benefit anyone who does not want to get COVID-19.”
“It could be useful not only in household settings but also in other exposure circumstances, such as outbreaks in nursing homes, chronic or acute care facilities and following travel-related exposures,” Hayden said.
The most common health issues in people who received the pill included headache, diarrhea, and cough.
Shionogi stated that it was confident in the drug’s safety profile, given that adverse event rates were about the same in the trial arm that received the pill and the placebo arm.