Acidemia, Isovaleric

Pictured: FDA signage at its office in Washington, DC/iStock, JHVEPhoto The FDA on Wednesday approved the use of UTILITY therapeutics’ oral antibiotic pivmecillinam, which will now carry the brand name Pivya, for the treatment of adult women with uncomplicated urinary tract infections. In its approval announcement, the FDA noted that uncomplicated urinary tract infections (UTIs) are bacterial infections of the bladder in females with no structural abnormalities of their urinary tract. The regulator added that approximately one-half of all women experience at least one UTI in their lifetime. Pivya is indicated for patients whose UTIs are caused by susceptible strains of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. UTILITY is working to make Pivya available in the U.S. in 2025, according to reporting from The New York Times. The antibiotic’s approval “will provide an additional treatment option for uncomplicated UTIs,” Peter Kim, director of the Division of Anti-Infectives at the FDA’s Center for Drugs Evaluation and Research, said in a statement. “Uncomplicated UTIs are a very common condition … and one of the most frequent reasons for antibiotic use.” The FDA’s approval on Wednesday was supported by data from three clinical trials, which compared Pivya to placebo, another oral antibacterial agent as well as to the anti-inflammatory drug ibuprofen. All three studies primarily evaluated Pivya’s composite response rate, which included clinical cure and microbiological response. In the placebo study, Pivya treatment elicited a 62% composite response rate at eight to 14 days after enrollment. Only 10% of placebo counterparts achieved the composite response endpoint. When compared with another antibacterial agent, Pivya elicited a 72% composite response rate versus 76% in those who received the other drug. In the third trial, 66% of patients treated with Pivya achieved composite response compared to only 22% of those who were given ibuprofen. In terms of safety, Pivya was overall well-tolerated and its most common side effects were nausea and diarrheas. The antibiotic carries warnings for hypersensitivity reactions, carnitine depletion, Clostridioides difficile-associated diarrhea and severe cutaneous adverse reactions. It should not be taken by patients with known histories of severe hypersensitivities against beta-lactam drugs. Pivya can also interfere with a newborn screening test for the rare metabolic disorder isovaleric acidemia. Pivya’s active ingredient pivmecillinam is an aminopenicillin, which is a specific subclass of beta-lactams that work by disrupting the synthesis of the bacterial cell wall. According to UTILITY’s website, pivmecillinam has already been commercially approved for more than 40 years outside the U.S. and has long been used to successfully treat UTIs. Pivmecillinam has also been recommended as the frontline treatment option in many countries. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Pivya is intended for treating UTIs. Credit: ANN PATCHANAN via Shutterstock. The US Food and Drug Administration (FDA) has approved Utility Therapeutics’ Pivya tablets, a new treatment for female adults with uncomplicated urinary tract infections (UTIs). This decision is based on the efficacy of Pivya in treating UTIs caused by susceptible Escherichia coli isolates , Staphylococcus saprophyticus and Proteus mirabilis. The approval was supported by three controlled clinical trials. These trials assessed the efficacy of Pivya in treating females aged 18 years or older with uncomplicated UTIs, comparing various dosing regimens of the drug to placebo, another oral antibacterial drug, and to anti-inflammatory drug ibuprofen. The trials’ primary efficacy measure was the composite response rate, which included both clinical cure and microbiological response. In the study comparing Pivya to placebo, 62% of the 137 participants receiving the therapy achieved the composite response, significantly higher than the 10% response rate in the placebo group. See Also: Mundipharma to acquire rezafungin assets from Cidara Therapeutics Novartis bags paediatric FDA label expansion for Lutathera When compared to another oral antibacterial drug, Pivya’s composite response rate was 72%, closely matching the comparator drug’s 76%. Against ibuprofen, Pivya showed a 66% response rate, compared to 22% for those who received the anti-inflammatory drug. Nausea and diarrhoea were the common side effects reported during the trials for Pivya. The FDA advises against the use of Pivya in patients with a history of severe hypersensitivity to beta-lactam antibacterial drugs, those with carnitine deficiency disorders, and individuals suffering from porphyria. Pivya carries warnings for potential hypersensitivity reactions, carnitine depletion, severe cutaneous adverse reactions, Clostridioides difficile-associated diarrhoea, and possible interference with newborn screening tests for metabolic disorder isovaleric acidemia. The FDA granted Pivya priority review and qualified infectious disease product designations. FDA Center for Drug Evaluation and Research Anti-Infectives division director Peter Kim said: “Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use. “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.”

SILVER SPRING, Md., April 24, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. "Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use," said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA's Center for Drug Evaluation and Research. "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." Uncomplicated UTIs are bacterial infections of the bladder in females with no structural abnormalities of their urinary tract. Approximately one-half of all women experience at least one UTI in their lifetime. Pivya's efficacy in treating females 18 years of age or older with uncomplicated UTIs was assessed in three controlled clinical trials comparing different Pivya dosing regimens to placebo, to another oral antibacterial drug and to ibuprofen (an anti-inflammatory drug). The primary measure of efficacy for the three trials was the composite response rate, which included clinical cure (resolution of the symptoms of the uncomplicated UTI that were present in patients at trial entry and no new symptoms) and microbiological response (demonstration that the bacteria cultured from patients' urine at trial entry was reduced). The composite response rate was assessed approximately 8 to 14 days after patients were enrolled into the studies. In the clinical trial comparing Pivya to placebo, 62% of the 137 subjects who received Pivya achieved the composite response compared to 10% of the 134 who received placebo. In the clinical trial comparing Pivya to another oral antibacterial drug, 72% of the 127 subjects who received Pivya achieved composite response compared to 76% of the 132 who received the comparator drug. In the clinical trial comparing Pivya to ibuprofen, 66% of the 105 subjects who received Pivya achieved composite response compared to 22% of the 119 who received ibuprofen. The most common side effects of Pivya included nausea and diarrhea. Patients should not use Pivya if they have a known history of severe hypersensitivity to Pivya or other beta-lactam antibacterial drugs. Patients should also not use Pivya if they have primary or secondary carnitine deficiency resulting from inherited disorders of mitochondrial fatty acid oxidation and carnitine metabolism, or if they are suffering from porphyria. Pivya comes with certain warnings and precautions such as hypersensitivity reactions, severe cutaneous adverse reactions, carnitine depletion, Clostridioides difficile-associated diarrhea and interference with a newborn screening test for isovaleric acidemia, a rare metabolic disorder. Pivya was granted Priority Review and Qualified Infectious Disease Product designations for this indication. The FDA granted the approval of Pivya to UTILITY therapeutics Ltd. Additional resources: Antimicrobial Resistance Information from FDA Media Contact: Chanapa Tantibanchachai, 202-384-2219 Consumer Inquiries: Email, 888-INFO-FDA The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. SOURCE U.S. Food and Drug Administration