Japan has given fast-tracked approval for a pioneering one-dose, anti-viral medication said to stop replication of the flu virus in the body within 24 hours of being taken. This claim makes the medication more faster acting for a number of infection markers than any available anti-viral medication for flu.
While complete recovery time for the ill may be similar to other medications, it is said to show in trials the ability to reduce fever more quickly, the time when a person who has the flu is infectious as well as to reduce side-effects.
Xofluza (baloxavir marboxil) is from Japanese pharmaceutical company Shionogi. Baloxavir marboxil is an endonuclease inhibitor that the company says has shown in trials to be active against both A and B viruses.
The company is working with Swiss drugmaker Roche Holding on marketing the drug globally, except in the Japan and Taiwan.
Roche is the maker of Tamiflu (oseltamivir), one of three anti-viral drugs approved for treatment of the flu in the United States. Tamiflu is taken in 10 doses over five days, a routine not always completed by patients, and is said best if taken within 48 hours of flu onset in terms of shortening the length of the illness.
One study showed it took median time of four days for Tamiflu to lessen flu symptoms in patients who took it, compared to five days in those who did not take it. Research has also shown it to be most effective in patients with laboratory confirmed cases of flu.
Tamiflu works by blocking a protein on the surface of flu viruses called neuraminidase that allows the replicated virus to spread from infected cells.
Baloxavir is said to inhibit the virus from replicating within an infected cell.
The Osaka-based Shionogi had received preliminary approval of its drug in January.
The company says non-clinical studies of its drug has shown resistance to oseltamivir-resistant flu strains and avian flu strains.
Roche is reportedly planning to seek FDA approval for the drug possibly in time for next year's flu season.
Anti-viral medications are not substitutes for the flu vaccine, but are given to relieve flu symptoms, particularly in patients at high risk for other complications from influenza.
A drug that suppresses replication of the flu virus with a single oral dose has been approved for sale in Japan.
Japanese drugmaker Shionogi on Friday announced that its Xofluza tablet had received approval from the Ministry of Health, Labour and Welfare.
The drug was reviewed under a fast-track process the ministry introduced in 2015 and will go on sale as soon as prices are set, the company said.
Xofluza has been lauded for its innovative mechanism and emerges as a rival to Tamiflu, a drug that requires two daily doses over five consecutive days.
With only one dose, Xofluza inhibits an enzyme that flu viruses need to replicate themselves. Tamiflu, on the other hand, does not suppress virus replication.
Shionogi predicts its new product will help reduce costs for patients and enhance infection control in homes and workplaces.
Xofluza is the first drug to be approved thr
Xofluza is the first drug to be approved through the fast-track review system. Titanbridge, a device to treat vocal disorders marketed by Tokyo-based company Nobelpharma, has been approved through the process.
Shionogi is working in conjunction with Swiss drugmaker Roche Holding on marketing Xofluza globally, except for in the Japan and Taiwan markets.
from Health - Google News http://ift.tt/2BMxqwK
No comments:
Post a Comment