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FDA approves a new kind of oral antibiotic to treat urinary tract infections

FDA approves a new kind of oral antibiotic to treat urinary tract infections
EIGHT. WELCOME BACK. SO NEW THIS MONTH. THE FDA IS REQUIRING ALL MAMMOGRAPHY REPORTS AND RESULT LETTERS TO ALSO INCLUDE AN ASSESSMENT OF BREAST DENSITY. WHY? WELL, BECAUSE THE RISK OF BREAST CANCER IS HIGHER FOR WOMEN WITH DENSE BREASTS. HERE TO BREAK IT ALL DOWN FOR US IS DOCTOR JAMIE SLOTKIN, A BREAST SURGEON AT WELLSPAN HEALTH. THANK YOU SO MUCH FOR JOINING US, DOCTOR. REALLY APPRECIATE YOUR TIME. THANK YOU SO MUCH FOR HAVING ME. SO FIRST, CAN YOU TALK ABOUT WHAT A DENSE BREAST IS? WHAT DOES IT MEAN IF A WOMAN HAS DENSE BREASTS? SURE. SO YOUR BREAST IS MADE UP OF A COMBINATION OF FAT AND GLANDULAR TISSUE. AND SO WHEN WE TALK ABOUT BREAST DENSITY, WE’RE NOT TALKING ABOUT HOW YOUR BREAST FEELS. WE’RE TALKING ABOUT HOW IT LOOKS ON A MAMMOGRAM, WHICH IS AN X RAY. SO WE’RE REALLY TALKING ABOUT HOW MUCH FAT VERSUS HOW MUCH GLANDULAR TISSUE A PATIENT HAS AND WHAT HAPPENS NOW WHEN A WOMAN GETS SCREENED. WHAT WILL THEY SEE ON THEIR MAMMOGRAPHY REPORT. SO ON THE REPORT, THE RADIOLOGIST WILL WRITE ANY FINDINGS THAT THEY SEE. AND ONE OF THE THINGS THAT THEY’LL INCLUDE IN THE REPORT IS HOW DENSE THE BREAST IS. AND WE PUT THAT INTO FOUR DIFFERENT CATEGORIES. WHAT’S NEW IS THAT IN THE PART OF THE REPORT THAT GOES TO THE PATIENT, IT WILL BE EXPLAINED IN LAY TERMS OR IN TERMS THAT ARE EASY TO UNDERSTAND WHAT THAT ACTUALLY MEANS. SO I UNDERSTAND ALREADY IN PENNSYLVANIA, SOME PATIENTS WERE GETTING THEIR BREAST DENSITY NOTIFICATION. CAN YOU TALK MORE ABOUT THAT? HOW WOMEN ARE NOTIFIED. THOSE DIFFERENT LABELS AND EXAMPLES BECAUSE MAYBE A LOT OF WOMEN WERE KIND OF DISMISSING IT ON THEIR REPORT. SURE. SO IN THE PAST, SINCE 2013, SINCE 2008, I’M SORRY IT’S BEEN REQUIRED THAT BREAST DENSITY BE LISTED IN YOUR REPORT ON A MAMMOGRAM. AND SO EVERY INSTITUTION WAS DOING THAT IN ITS OWN WAY TO FOLLOW THE LAW. THE NEW LAW SAYS THAT IT HAS TO BE DONE IN A CERTAIN WAY WITH THE SAME LANGUAGE FOR EVERY SINGLE PATIENT, WHICH I THINK ALLEVIATES A LOT OF THE CONFUSION. SO THERE WILL BE A PART OF THE REPORT THAT’S IN DOCTOR TALK THAT SAYS THAT YOU HAVE, FOR EXAMPLE, HETEROGENEOUSLY DENSE BREASTS. RIGHT. AND SO WE BREAK IT DOWN INTO FOUR CATEGORIES. SO WE HAVE FATTY BREAST WHICH MEANS THERE’S NOT REALLY ANY BREAST DENSITY. OR YOU HAVE SCATTERED FIBER GLANDULAR TISSUE WHICH IS AVERAGE OKAY. THAT’S NORMAL. AND THEN FOR INCREASED BREAST DENSITY YOU EITHER HAVE HETEROGENEOUSLY DENSE BREAST OR EXTREMELY DENSE BREASTS. AND NOW ON THE MAMMOGRAM REPORT YOU WILL SEE A STATEMENT THAT SAYS THAT SOME WOMEN HAVE INCREASED BREAST DENSITY. AND WOMEN WHO HAVE INCREASED BREAST DENSITY MAY LOWER THE SENSITIVITY OF THEIR MAMMOGRAM OR MAY INCREASE THE RISK OF BREAST CANCER. AND THEN THERE WILL BE A STATEMENT THAT SAYS YOU DO OR DO NOT HAVE INCREASED BREAST DENSITY, WHICH I THINK WILL BE VERY HELPFUL FOR PATIENTS TO UNDERSTAND WHAT THOSE REPORTS MEAN AND HOW IT APPLIES TO THEM PERSONALLY. YEAH. SO I WAS READING ABOUT HOW SO MANY BREAST CANCER PATIENTS ARE DIAGNOSED AT LATE STAGES WHEN THE DISEASE IS MOST DEADLY AND HARD TO TREAT. IS THIS WHY? BECAUSE MAMMOGRAMS WEREN’T DETECTING IN DENSE BREASTS? OR CAN YOU TALK ABOUT HOW THIS IS ADDING THIS NOTIFICATION IS POSSIBLY CHANGING THAT? SURE. SO AS WE ALL KNOW, MAMMOGRAMS SAVE LIVES, RIGHT? MAMMOGRAMS ARE AN EXCELLENT SCREENING TOOL FOR BREAST CANCERS. THEY FIND ABOUT 85% OF BREAST CANCERS FINDING BREAST CANCER EARLY IS KEY TO THE BEST PROGNOSIS AND THE BEST OVERALL SURVIVAL. SO GETTING A MAMMOGRAM IS THE MOST IMPORTANT THING YOU CAN DO TO FIND A CANCER EARLY. WOMEN WHO HAVE DENSE BREASTS I THINK THAT’S IMPORTANT FOR TWO REASONS. THE FIRST REASON IS, AS YOU SAID, WHEN WE HAVE REALLY DENSE BREASTS, IT MAKES IT HARDER FOR THE FOR THE RADIOLOGIST TO SEE THROUGH OUR BREASTS. RIGHT. TUMORS ARE WHITE AND DENSE. BREAST TISSUE IS WHITE. SO IT ALL LOOKS THE SAME. SO A MAMMOGRAM IS A LITTLE BIT LESS SENSITIVE IN WOMEN WHO HAVE VERY DENSE BREASTS. BUT THE OTHER REALLY KEY IMPORTANT FACTOR OF THIS IS THAT HAVING INCREASED BREAST DENSITY IS ACTUALLY AN INDEPENDENT RISK FACTOR FOR DEVELOPING BREASTS FOR FOR DEVELOPING BREAST CANCER. SO IF YOU HAVE DENSE BREAST, YOU HAVE A HIGHER RISK OF BREAST CANCER. AND IT’S HARDER TO DETECT ON A REGULAR MAMMOGRAM. SO IF A WOMAN GETS A REPORT NOW THAT SAYS, HEY, YOUR BREASTS ARE DENSE, WHAT DO THEY DO NEXT? IF A STANDARD MAMMOGRAM MAY NOT BE ENOUGH? SO THERE WILL BE A STATEMENT THAT SAYS, HEY, YOU HAVE DENSE BREASTS AND YOU MIGHT NEED SOME EXTRA IMAGING. SO FOR SOME WOMEN WHO HAVE INCREASED BREAST DENSITY, WE TALK ABOUT DOING EXTRA IMAGING SO WE DON’T GET RID OF YOUR MAMMOGRAMS BECAUSE THEY’RE A GREAT SCREENING TOOL. SO YOU STILL NEED A REGULAR MAMMOGRAM EVERY YEAR. BUT FOR SOME WOMEN IT’S BENEFICIAL TO DO EXTRA SCREENING. AND YOU CAN DO THAT IN A VARIETY OF WAYS. USUALLY WE DO THAT WITH EITHER AN MRI AT WELLSPAN, WE DO CONTRAST ENHANCED MAMMOGRAMS. SO IT’S A MAMMOGRAM WHERE WE GIVE YOU IV CONTRAST SO IT CAN LIGHT UP ANY AREAS THAT ARE ABNORMAL. OR OCCASIONALLY WE’LL DO AN ULTRASOUND. AWESOME. GREAT INFORMATION. THANK YOU SO MUCH,
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FDA approves a new kind of oral antibiotic to treat urinary tract infections
The U.S. Food and Drug Administration has approved a new type of antibiotic to treat urinary tract infections. The pill, gepotidacin, will be sold under the brand name Blujepa and is expected to be available in the second half of 2025.Video above: Mammogram reports must now include breast density informationBlujepa is approved to treat females 12 and older with uncomplicated urinary tract infections, or UTIs. About half of all women will experience a UTI at some point in their lives, and about 30% will have a UTI that comes back after treatment, drugmaker GSK said.Recurrent UTIs have become a bigger problem as the bacteria that cause them have become more resistant to the antibiotics available to treat them.Blujepa is the first new type of oral antibiotic to treat UTIs to gain approval in more than 20 years. Its development was funded in part by grants from the US government's Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.Dr. Tony Wood, chief scientific officer of GSK, said in a statement that Blujepa's approval is "a crucial milestone.""We are proud to have developed Blujepa, the first in a new class of oral antibiotics for in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments," the statement said.Other antibiotics have recently been approved for UTIs, although they fit into existing drug classes. Pivya, a type of penicillin, was approved in April 2024 to treat uncomplicated UTIs, and Orlynvah was approved in December 2024 to treat uncomplicated UTIs in women who have limited or no other antibiotic treatment options. Blujepa is what's known as a triazaacenaphthylene antibiotic and it's the first of its kind.UTIs are the cause of roughly 8 million emergency room visits and 100,000 hospitalizations in the US each year, GSK said. They strike women more often than men.Blujepa works by interfering with two enzymes that bacteria need to copy themselves. Because its mechanism of action is targeted, it may cut down on the possibility that bacteria will become resistant to it, Wood said Monday during a call with reporters.In clinical trials with more than 3,000 women and teen girls, the drug - a pill taken twice daily - performed as well as or better than nitrofurantoin, the frontline antibiotic which is currently used to treat UTIs.Its main side effects were diarrhea, which affected 16% of patients in the clinical trial, and nausea, which affected 9% of participants. Most of these events were considered mild.Symptoms of UTIs include frequent urination that is painful or burns, bloody urine, low stomach cramps and the need to urinate even after having just gone.

The U.S. Food and Drug Administration has approved a new type of antibiotic to treat urinary tract infections. The pill, gepotidacin, will be sold under the brand name Blujepa and is expected to be available in the second half of 2025.

Video above: Mammogram reports must now include breast density information

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Blujepa is approved to treat females 12 and older with uncomplicated urinary tract infections, or UTIs. About half of all women will experience a UTI at some point in their lives, and about 30% will have a UTI that comes back after treatment, drugmaker GSK said.

Recurrent UTIs have become a bigger problem as the bacteria that cause them have become more resistant to the antibiotics available to treat them.

Blujepa is the first new type of oral antibiotic to treat UTIs to gain approval in more than 20 years. Its development was funded in part by grants from the US government's Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.

Dr. Tony Wood, chief scientific officer of GSK, said in a statement that Blujepa's approval is "a crucial milestone."

"We are proud to have developed Blujepa, the first in a new class of oral antibiotics for [uncomplicated UTIs] in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments," the statement said.

Other antibiotics have recently been approved for UTIs, although they fit into existing drug classes. Pivya, a type of penicillin, in April 2024 to treat uncomplicated UTIs, and Orlynvah in December 2024 to treat uncomplicated UTIs in women who have limited or no other antibiotic treatment options. Blujepa is what's known as a triazaacenaphthylene antibiotic and it's the first of its kind.

UTIs are the cause of roughly 8 million emergency room visits and 100,000 hospitalizations in the US each year, GSK said. They strike women more often than men.

Blujepa works by interfering with two enzymes that bacteria need to copy themselves. Because its mechanism of action is targeted, it may cut down on the possibility that bacteria will become resistant to it, Wood said Monday during a call with reporters.

In clinical trials with more than 3,000 women and teen girls, the drug - a pill taken twice daily - performed as well as or better than nitrofurantoin, the frontline antibiotic which is currently used to treat UTIs.

Its main side effects were diarrhea, which affected 16% of patients in the clinical trial, and nausea, which affected 9% of participants. Most of these events were considered mild.

Symptoms of UTIs include frequent urination that is painful or burns, bloody urine, low stomach cramps and the need to urinate even after having just gone.