A new influenza treatment has arrived in Korea in over 20 years.
The Ministry of Food and Drug Safety recently approved Roche’s Xofluza (ingredient: baloxavir marboxil) as a treatment for influenza A or B infection in people aged 12 and older.
Xofluza is an antiviral with a new mechanism that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication. The drug prevents progression from the initial stage of virus replication and prevents virus propagation, the company said.
Xofluza, one-dose oral medication, can quickly relieve flu symptoms and shorten the time it takes for the flu virus to be detected, which will prevent the transmission of the virus, Roche added.
The regulator gave the nod based on the results of a CAPSTONE-1 clinical study in patients aged between 12 and 64 with acute influenza who did not have complications, and the CAPSTONE-2 clinical study in high-risk flu patients 12 years of age and older.
The CAPSTONE-1 clinical study compared Xofluza with placebo or oseltamivir in 1,064 patients aged between 12 and 64 with acute influenza who did not have complications. The primary endpoint was time taken to alleviate the symptoms of the patients.
The results showed that the median time to symptomatic relief was 53.7 hours in the Xofluza-treated group, versus 80.2 hours in the placebo-administered group. The Xofluza group was 26.5 hours quicker in the alleviation of symptoms than the placebo group.
Lee Hee-jung, director at the Specialized Care of Roche Korea, said Xofluza is an innovative treatment option that improves influenza symptoms more quickly with just one oral dose.
“Its new mechanism of suppressing the replication of flu virus and shortening the time to detect the virus is expected to contribute not only to managing flu symptoms but also to preventing transmission,” she said.
Xofluza won the Japanese regulatory permit in February 2018, and the U.S. FDA approval in October the same year.