New flu drug will be in pharmacies soon
FDA approves prescription pill that would shorten illness by blocking virus replication
The new drug approved this week by the FDA to treat the flu is not yet available in Houston pharmacies, but will be soon, according to distributor Genentech.
Xofluza (baloxavir marboxil), a single-dose antiviral, is the first new flu treatment approved in nearly 20 years, according to the Food and Drug Administration Commissioner Dr. Scott Gottlieb. It’s a pill designed to reduce symptoms and shorten the flu’s duration.
The drug is an oral medication for people who have developed flu symptoms in the past 48 hours. If it’s taken in time, an antiviral drug like Xofluza “can lessen symptoms and shorten the time patients feel sick,” Dr. Debra Birnkrant, director of the antiviral products division in the FDA’s Center for Drug Evaluation and Research, said in a statement this week.
The rate of flu and flu-related pneumonia was particularly bad last year. Nearly 10,000 Texans died from the flu, according to state health officials, including 2,150 in the Houston area.
Xofluza is not the same thing as a flu shot. The prescription drug, designed to treat a person who already has symptoms of the flu, shortens the illness by stopping the virus from replicating. A flu vaccine causes antibodies to develop in the body to fight the infection. People can get a flu shot and then take Xofluza if they still get the flu.
The FDA announced its approval of Xofluza on Wednesday, and pharmacies will now have to order the pill from the supplier. It’ll be widely available within a few weeks, distributor Genentech said this week.
In the clinical trials for Xofluza, patients recovered from flu symptoms in 2.3 days. That’s 54 hours, versus 80 hours for those taking the placebo.
For Xofluza to work, patients 12 and older have to take it no more than 48 hours after flu symptoms — fever, aches, chills, runny nose, sore throat and sneezing — first appear. Otherwise, it may be too late for the drug to stop the virus from replicating.
During clinical trials, the most common Xofluza side effects included diarrhea and bronchitis. The clinical trials did not include people 65 and older. And the medication is not intended for children under 12 years old.
Without insurance, a single pill will cost $150, according to a spokesman for Genentech. With insurance and a coupon available on the distributor’s website at www.xofluza.com, the cost might be reduced to as low as $30.