US FDA approves first enzyme-blocking antiviral in 20 years
Xofluza (baloxavir marboxil) was approved by the US Food and Drug Administration (FDA) as an additional treatment option to provide an effective alternative to current drugs to treat influenza.
Genentech, a subsidiary of Roche, is the distributor of this treatment, in addition to its other flu treatment, Tamiflu – which has been supported by the Centre for Disease Control (CDC) during times of particularly infectious and severe flu seasons.
According to Andrew Villani, senior manager of corporate relations at Genentech, severe flu seasons like last year’s made the drug a large priority.
“New treatment options for the flu are important. The severity of last year’s flu season underscores the need for new medical options beyond currently available antivirals,” he explained.
According to a statement made by the director of the division of antiviral products in the FDA’s Center for Drug Evaluation and Research, having more treatment options that work in different ways to attack the virus is imperative.
According to an FDA spokesperson, “There are three FDA-approved influenza antiviral drugs recommended by CDC for use against recently circulating influenza viruses.”
Villani told us that Xofluza has a mechanism of action that blocks an enzyme within the flu virus. This enzyme stops replication early in the influenza lifecycle. The treatment has demonstrated efficacy against a range of influenza viruses, including two strains resistant to treatment and avian strains, in non-clinical studies.
This FDA approval comes after the safety and efficacy of Xofluza were demonstrated in two clinical trials. In both trials, patients treated with Xofluza had symptoms for a shorter time as compared to patients who took the placebo. In a second trial, there was no difference in time between the patients who received Xofluza and those who received another influenza medication.
Xofluza was granted priority review in which the FDA took action on the application within an expedited timeframe, as the agency determined that the drug could significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
The FDA has approved this new treatment for those who have already contracted the flu, the agency says there is no safer way to combat the flu than with a preventative flu shot.
