FDA approves Pivya for simple UTIs

More than half of all women will have a urinary tract infection (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.

“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 statement. “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.” 

What is Pivya?

Pivya is an oral antibiotic that has been shown to be very effective in combating common causes of uncomplicated UTIs, such as E. coli, Proteus mirabilis, and Staphylococcus saprophyticus bacteria.

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

How does Pivya work?

The active antimicrobial agent of pivmecillinam 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 targets a protein called the penicillin binding protein-2 (PBP-2) in the cell wall of gram-negative bacteria.

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

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 treatment with antibiotics. 

The most commonly prescribed antibiotics for simple UTIs include:

• Bactrim, Bactrim DS (trimethoprim and sulfamethoxazole) 
• Monurol (fosfomycin) 
• Macrobid (nitrofurantoin)
• Keflex (cephalexin)
• Ceftriaxone

Sometimes, people who get frequent UTIs are prescribed a daily, low-dose antibiotic to ward off future infections. However, concern over antibiotic resistance has continued to grow in recent years. The FDA calls it a “serious, complex, and costly public health problem.” Contributing factors include the overprescription of antibiotics or the inappropriate use of antibiotics to treat viral infections (antibiotics do not work against viruses).

Pivya will support decreased antibiotic resistance while still curing painful UTIs. According to Utility Therapeutics Ltd., oral pivmecillinam has long been a key treatment for UTIs in Denmark since the 1970s, and despite its widespread use, the resistance rates have remained low. 

What are the possible side effects of Pivya?

The most common side effects associated with taking Pivya are nausea and diarrhea. 

However, like any medication, other side effects and complications are possible. Pivya comes with warnings about severe allergic and skin reactions, carnitine depletion, and C. diff colitis. The medication may also interfere with a newborn screening test for a rare metabolic disorder called isovaleric acidemia.

Some people should not take Pivya, including people who are sensitive to beta-lactam antibiotics (like penicillin), have a carnitine deficiency, or have porphyria, a rare disorder that affects the skin and nervous system. 

When will Pivya be available?

Pivya will be available in tablet form. However, Utility Therapeutics has not announced when the medication will hit U.S. shelves. The company is also developing an intravenous (IV) formulation of mecillinam to treat complicated UTIs

How much will Pivya cost?

Utility Therapeutics has not announced pricing for Pivya.