Latest news with #SovrinShah
Yahoo
14-04-2025
- Health
- Yahoo
A new type of antibiotic pill may treat drug-resistant gonorrhea. It could be available this year.
A pill developed by GSK was found to be safe and effective in treating gonorrhea in a late-stage clinical trial, according to a study published Monday in The Lancet. If approved, it would become the first new class of antibiotic for the sexually transmitted infection in more than two decades. The pill, called gepotidacin, was approved by the Food and Drug Administration in March to treat uncomplicated urinary tract infections in women and girls 12 and up — the most common type of infection in women. The drug is sold under the name Blujepa. A new treatment option is important, experts say, because bacteria that commonly cause STIs are increasingly becoming resistant to the standard antibiotics, making treatment more difficult. There are an estimated 82 million new cases of gonorrhea globally each year, according to GSK. In the United States, rates of reported gonorrhea have increased 118% from 2009 to 2021, with more than 640,000 cases being reported to the Centers for Disease Control and Prevention in 2022. Gonorrhea has developed resistance to nearly all the antibiotics used for its treatment, according to the CDC. If left untreated, gonorrhea can lead to serious health complications, including swollen and painful joints, liver inflammation, and heart and brain damage. It can also increase the risk of infertility in women. Gepotidacin is part of a new class of antibiotics called triazaacenaphthylenes, which work by targeting two key enzymes that gonorrhea needs to copy itself and survive. In a Phase 3 clinical trial of more than 600 adults and teens, gepotidacin was shown to successfully treat about 92% of patients when taken twice daily, compared with about 91% in a group of patients who got a standard treatment. The most common side effect was gastrointestinal issues, with almost all reported being 'mild or moderate.' Crucially, the study authors wrote, the pill was effective against strains of gonorrhea bacteria that are resistant to existing antibiotics. Dr. Sovrin Shah, an associate professor of urology at Mount Sinai Hospital in New York who was not involved in the study, called the GSK pill 'a welcome addition.' 'Antibiotic-resistant gonorrhea is a public health concern,' Shah said. 'The rate of STIs is significant in the U.S.' David Harvey, executive director of the National Coalition of STD Directors, said 'we desperately need effective cures to combat gonorrhea,' but noted that widespread job cuts at the federal health agencies, including to a lab that tracked STIs, could make it challenging. 'The recent closure of the CDC's key STI lab — which helps us understand which antibiotics are still effective and when we need to engage new drugs like this — poses a significant new obstacle,' Harvey said. A spokesperson for GSK said the company plans to file approval with the FDA 'in the coming months' with a regulatory decision expected in the second half of the year. The company said it's seeking approval for gepotidacin as an alternative to first-line therapy when such treatment is inappropriate — such as when the patient is intolerant to the existing treatment or unwilling to use it. In an editorial that accompanied the study, Magnus Unemo, director of the World Health Organization's division that oversees gonorrhea, said GSK's pill is 'promising,' but added that challenges to keep gonorrhea as a treatable infection will continue. Unemo also stressed improved prevention, including the promotion of safe sex and condom use, early diagnosis and surveillance. This article was originally published on
NBC News
14-04-2025
- Health
- NBC News
New pill is effective against gonorrhea as antibiotic resistance surges, study shows
A pill developed by GSK was found to be safe and effective in treating gonorrhea in a late-stage clinical trial, according to a study published Monday in The Lancet. If approved, it would become the first new class of antibiotic for the sexually transmitted infection in more than two decades. The pill, called gepotidacin, was approved by the Food and Drug Administration in March to treat uncomplicated urinary tract infections in women and girls 12 and up — the most common type of infection in women. The drug is sold under the name Blujepa. A new treatment option is important, experts say, because bacteria that commonly cause STDs are increasingly becoming resistant to the standard antibiotics, making treatment more difficult. There are an estimated 82 million new cases of gonorrhea globally each year, according to GSK. In the United States, rates of reported gonorrhea have increased 118% from 2009 to 2021, with more than 640,000 cases being reported to the Centers for Disease Control and Prevention in 2022. Gonorrhea has developed resistance to nearly all the antibiotics used for its treatment, according to the CDC. If left untreated, gonorrhea can lead to serious health complications, including swollen and painful joints, liver inflammation and heart and brain damage. It can also increase the risk of infertility in women. Gepotidacin is part of a new class of antibiotics called triazaacenaphthylenes, which work by targeting two key enzymes that gonorrhea needs to copy itself and survive. In a phase 3 clinical trial of more than 600 adults and teens, gepotidacin was shown to successfully treat about 92% of patients when taken twice daily, compared to about 91% in a group of patients who got a standard treatment. The most common side effect was gastrointestinal issues, with almost all reported being 'mild or moderate.' Crucially, the study authors wrote, the pill was effective against strains of gonorrhea bacteria that are resistant to existing antibiotics. Dr. Sovrin Shah, an associate professor of urology at Mount Sinai Hospital in New York who was not involved in the study, called the GSK pill 'a welcome addition.' 'Antibiotic-resistant gonorrhea is a public health concern,' Shah said. 'The rate of STIs is significant in the U.S.' A spokesperson for GSK said the company plans to file approval with the FDA 'in the coming months' with a regulatory decision expected in the second half of the year. The company said it's seeking approval for gepotidacin as an alternative to first-line therapy when such treatment is inappropriate — such as when the patient is intolerant to the existing treatment or unwilling to use it. The company is also investigating whether gepotidacin works in other sexually transmitted diseases. In an editorial that accompanied the study, Magnus Unemo, director of the World Health Organization's division that oversees gonorrhea, said GSK's pill is 'promising,' but added that challenges to keep gonorrhea as a treatable infection will continue. Unemo also stressed improved prevention, including the promotion of safe sex and condom use, early diagnosis and surveillance.
Yahoo
25-03-2025
- Health
- Yahoo
FDA approves first new antibiotic for UTIs in nearly 30 years
The Food and Drug Administration on Tuesday approved the first drug in a new class of antibiotics for treating urinary tract infections — the first time that's happened in nearly 30 years. The drug, a pill called Blujepa from drugmaker GSK, was approved for women and girls 12 and up with uncomplicated UTIs — the most common type of the infection in women, often caused by bacteria including E. coli. Most UTIs are easy to treat, usually clearing up within a few days or weeks after a short course of antibiotics. But the bacteria that commonly cause them are increasingly becoming resistant to the standard antibiotics, making treatment more difficult, said Dr. Sovrin Shah, an associate professor of urology at Mount Sinai Hospital in New York. More than 2.8 million antimicrobial-resistant infections occur in the U.S. each year, according to the Centers for Disease Control and Prevention. A 2019 study found resistance to at least one drug in more than 92% of bacteria that can cause UTIs. Around 80% showed resistance to at least two. Developing new antibiotics that attack bacteria in different ways reduces the risk of drug resistance, helping to keep treatment options open, said Dr. Candace Granberg, a pediatric urologist and surgeon-in-chief at Mayo Clinic Children's in Rochester, Minnesota. UTI symptoms include a burning feeling when urinating, blood in the urine, a strong urge to urinate and urinating more often. Untreated, they can lead to complications including bladder infections and kidney damage. 'We absolutely need new antibiotics for uncomplicated UTIs,' Granberg said. Blujepa is part of a new class of antibiotics called triazaacenaphthylenes, which work by targeting two key enzymes that E. coli bacteria need to copy itself and survive. 'In simple terms, this new antibiotic works its magic by using a novel binding method to block a bacteria's ability to replicate,' Granberg said. According to GSK, the last time the FDA cleared a new class of antibiotics for uncomplicated UTIs was in 1996, with the approval of fosfomycin. (Last year, the agency approved the drug Pivya for UTIs, which belongs to the penicillin drug class.) In two phase 3 clinical trials of 3,000 adults and teens, Blujepa was shown to successfully treat 50% to 58% of patients' infections when taken twice a day for five days, compared to 43% to 47% in a group that received the antibiotic nitrofurantoin. More than half of women will experience at least one UTI in their lifetime, according to a 2019 report, and around 30% will experience a recurring infection. GSK is also studying whether the drug can treat gonorrhea, according to Tony Wood, the company's chief scientific officer. Blujepa is expected to be available in the second half of the year. Wood didn't disclose how much it would cost — although, as a brand-name drug, its cost is expected to be higher than other antibiotics that have been on the market for years and have generic options. Shah, of Mount Sinai Hospital, said that cost is an important consideration, noting that physicians would likely gravitate toward generics. Still, the overuse of the same antibiotics can promote drug resistance, so a new option is helpful, he added. This article was originally published on
NBC News
25-03-2025
- Health
- NBC News
FDA approves first new antibiotic for UTIs in nearly 30 years
The Food and Drug Administration on Tuesday approved the first drug in a new class of antibiotics for treating urinary tract infections — the first time that's happened in nearly 30 years. The drug, a pill called Blujepa from drugmaker GSK, was approved for women and girls 12 and up with uncomplicated UTIs — the most common type of the infection in women, often caused by bacteria including E. coli. Most UTIs are easy to treat, usually clearing up within a few days or weeks after a short course of antibiotics. But the bacteria that commonly cause them are increasingly becoming resistant to the standard antibiotics, making treatment more difficult, said Dr. Sovrin Shah, an associate professor of urology at Mount Sinai Hospital in New York. More than 2.8 million antimicrobial-resistant infections occur in the U.S. each year, according to the Centers for Disease Control and Prevention. A 2019 study found resistance to at least one drug in more than 92% of bacteria that can cause UTIs. Around 80% showed resistance to at least two. Developing new antibiotics that attack bacteria in different ways reduces the risk of drug resistance, helping to keep treatment options open, said Dr. Candace Granberg, a pediatric urologist and surgeon-in-chief at Mayo Clinic Children's in Rochester, Minnesota. UTI symptoms include a burning feeling when urinating, blood in the urine, a strong urge to urinate and urinating more often. Untreated, they can lead to complications including bladder infections and kidney damage. 'We absolutely need new antibiotics for uncomplicated UTIs,' Granberg said. Blujepa is part of a new class of antibiotics called triazaacenaphthylenes, which work by targeting two key enzymes that E. coli bacteria need to copy itself and survive. 'In simple terms, this new antibiotic works its magic by using a novel binding method to block a bacteria's ability to replicate,' Granberg said. According to GSK, the last time the FDA cleared a new class of antibiotics for uncomplicated UTIs was in 1996, with the approval of fosfomycin. (Last year, the agency approved the drug Pivya for UTIs, which belongs to the penicillin drug class.) In two phase 3 clinical trials of 3,000 adults and teens, Blujepa was shown to successfully treat 50% to 58% of patients' infections when taken twice a day for five days, compared to 43% to 47% in a group that received the antibiotic nitrofurantoin. More than half of women will experience at least one UTI in their lifetime, according to a 2019 report, and around 30% will experience a recurring infection. GSK is also studying whether the drug can treat gonorrhea, according to Tony Wood, the company's chief scientific officer. Blujepa is expected to be available in the second half of the year. Wood didn't disclose how much it would cost — although, as a brand-name drug, its cost is expected to be higher than other antibiotics that have been on the market for years and have generic options. Shah, of Mount Sinai Hospital, said that cost is an important consideration, noting that physicians would likely gravitate toward generics. Still, the overuse of the same antibiotics can promote drug resistance, so a new option is helpful, he added.
