{"id":627959,"date":"2024-04-29T10:19:03","date_gmt":"2024-04-29T14:19:03","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=627959"},"modified":"2024-10-25T09:59:35","modified_gmt":"2024-10-25T13:59:35","slug":"pivya-fda-approval","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/pivya-fda-approval\/","title":{"rendered":"FDA approves Pivya for simple UTIs"},"content":{"rendered":"

More than half of all women<\/span><\/a> will have a <\/span>urinary tract infection<\/span><\/a> (UTI) at some point in their lives. On April 24, the U.S. Food and Drug Administration approved Pivya (pivmecillinam), a prescription medication for the treatment of uncomplicated UTIs in female adults. An uncomplicated UTI is one that affects a woman’s bladder without any structural abnormalities in the urinary tract. It provides a new antibiotic option since resistance to first-line treatments is growing.<\/span><\/p>\n

“Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” said Peter Kim, MD, director of the Division of Anti-Infectives for the FDA’s Center for Drug Evaluation and Research in a <\/span>statement<\/span><\/a>. “The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Pivya will provide an additional treatment option for uncomplicated UTIs.” <\/span><\/p>\n

What is Pivya?<\/span><\/h2>\n

Pivya is an oral antibiotic that has been shown to be <\/span>very effective<\/span><\/a> in combating common causes of uncomplicated UTIs, such as<\/span> E. coli, Proteus mirabili<\/span><\/i>s, and <\/span>Staphylococcus saprophyticus<\/span><\/i> bacteria.<\/span><\/p>\n

Pivmecillinam is not actually a new antibiotic. It’s been <\/span>used to treat bacterial infections in Europe for more than 40 years<\/span><\/a>. With the recent approval, the U.K.-based biotechnology company Utility Therapeutics Ltd. is making this proven treatment available in the United States. <\/span><\/p>\n

How does Pivya work?<\/span><\/h2>\n

The active antimicrobial agent of <\/span>pivmecillinam<\/span><\/a> is mecillinam, which is categorized as an aminopenicillin, a specific class of beta-lactam antibiotics with a distinct mechanism of action (the way it works). Specifically, it <\/span>targets a protein called the penicillin binding protein-2 (PBP-2)<\/span><\/a> in the cell wall of gram-negative bacteria.<\/span><\/p>\n

Urinary tract infections occur when bacteria enter the urinary system, causing infection and inflammation. They’re significantly more common in women than in men. <\/span>Common symptoms<\/span><\/a> include pain and burning during urination, a frequent urge to urinate, and cloudy urine. <\/span><\/p>\n

Many people turn to home remedies, such as cranberry juice, water, and probiotics, to attempt to treat these painful infections or prevent them before they occur. However, most UTIs require <\/span>treatment with antibiotics<\/span><\/a>. <\/span><\/p>\n

The <\/span>most commonly prescribed antibiotics<\/span><\/a> for simple UTIs include:<\/span><\/p>\n