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The Food and Drug Administration announced Wednesday it has approved the first new influenza drug with an innovative mechanism for nearly 20 years. The drug, Xofluza, is placed on the US market by Genentech, a division of Roche.
Approval comes just in time for the influenza season, which should really begin in the coming weeks.
The drug is a fast-acting treatment, taken in a single dose. One dose may be one or two tablets, depending on the body weight of the person taking the medication. A person with the flu should take it shortly after the onset of symptoms to get the most out of the treatment.
The drug has already been licensed in Japan, where it is sold by Shionogi & Co. Roche has bought most of the world's rights to the drug, although Shionogi retains rights in Japan and Taiwan.
"With thousands of people contracting the flu each year and many people becoming seriously ill, safe and effective substitution treatment is essential." Said FDA Commissioner Scott Gottlieb, in which he announced his approval. "This new drug provides an important additional treatment option."
Genentech said that the wholesale price of the drug would be $ 150, that the prescription requires one or two tablets. It's on an equal footing, the company said, along with other flu drugs, including the best known, Tamiflu.
A spokesman for Genentech said by email that the company would offer a coupon to eligible patients during the next influenza season, which would mean that people whose health insurance covers the drug and who use the coupon could pay as little as $ 30 for Xofluza during his first treatment. year on the market. The coupon will reduce the price of the drug by $ 60 for people who do not have insurance, the spokesman said.
Experts predicted that prices would likely play a role in Xofluza's acceptance by the market. Tamiflu – which one study suggests works as well as Xofluza – has not proven to be extremely popular. With Xofluza, however, the convenience factor of a punctual dosing regimen can make the difference. Tamiflu should be taken twice a day for five days.
The FDA approval process was fast. The agency announced in late June that it would review the drug first and it should make its decision by Christmas. The company said that if the drug was approved, it would be effective to bring Xofluza into the distribution channel for the influenza season.
Xofluza has been approved for use in people 12 years of age and older who have had flu symptoms for less than 48 hours.
It is the first drug of a new class called endonuclease inhibitors. They work by interrupting viral replication – the process by which invading viruses seize the inner workings of cells to create hordes of copies of themselves to further spread the infection.
The drug works quickly, but must also be taken quickly to achieve maximum effect. The studies used to support his license application revealed that people who took the drug within 24 hours of the onset of symptoms felt better, on average 33 hours earlier than people whose flu did not. had not been treated. But for those who started treatment later, their recovery was accelerated only about 13 hours.
Experts acknowledged that this meant that there could be real obstacles to the use of the drug. Patients will need to obtain a prescription and have it filled in a few hours after they begin to feel sick to receive the benefits.
The FDA noted that the most common adverse reactions in patients taking Xofluza included diarrhea and bronchitis.
Republished with permission of STAT. This article was published on October 24, 2018.
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