Pivya Approved to Treat Urinary Tract Infections

On April 24, 2024, the U.S. Food and Drug Administration (FDA) approved Pivya (pivmecillinam – Utility Therapeutics) tablets under its Priority Review Process. The beta-lactam antibiotic is indicated to treat women who are at least 18 years old and who have uncomplicated urinary tract infections (uUTIs) that result from specific bacteria. It has been available in Europe and other parts of the world for several decades. In a clinical trial, infections cleared for 62% of patients taking Pivya as opposed to 10% of those taking a placebo. Results from a head-to-head comparison with cephalexin were comparable with Pivya producing a 72% complete response (CR) rate versus a slightly higher 76% CR rate for cephalexin. The recommended dose for Pivya is one tablet (185mg) three times a day for three days to seven days. Common adverse effects for patients were diarrhea and nausea. Pivya was designated as a Qualified Infectious Disease Product, which expedited its approval and granted the manufacturer five additional years of exclusivity. No information on its cost or launch has been released. Look here for its full prescribing information.

New Naloxone Products Approved

Naloxone provides temporary reversal of opioid overdoses in emergency settings. By blocking opioid receptors, it displaces the opioid drug and decreases the negative effects of a drug overdose. One dose (one spray or injection) should be given as soon as an overdose is observed or suspected, based on the patient’s breathing difficulty and unconsciousness. Emergency medical help should be requested immediately and additional doses may be administered if the patient does not revive or relapses after the initial dose. Naloxone nasal spray, 4mg/0.1mL, can be dispensed at pharmacies without a prescription, prescribed for a caregiver of an at-risk patient, or obtained at emergency services facilities (usually police and fire stations), depending on state regulations. Another intranasal product, Kloxxado^® (naloxone nasal spray, 8mg/0.1mL) is prescription-only. Two products, Narcan^® (naloxone – Emergent BioSolutions) 4mg/0.1mL nasal spray and RiVive (naloxone – Harm Reduction Therapeutics) nasal spray, 3mg/0.1mL, are available over the counter (OTC). Injectable forms of naloxone are dispensed only with a prescription. All the products are packaged as two units per box.

A new prescription brand, Rezenopy (naloxone hydrochloride) nasal spray, was approved by the FDA on April 19, 2024. It contains a higher strength per dose (10mg/0.1mL) than the other naloxone products currently available in the U.S. If needed, one additional spray can be given in the opposite nostril if the first is unsuccessful, but no more than two doses should be given in any 24 hours. Rezenopy was developed by Summit Biosciences which recently was sold to Kindeva Drug Delivery. No details on cost, distribution, or launch for Rezenopy have been announced. Here is its prescribing information.

On April 23, 2024, Amneal Pharmaceuticals received FDA approval and launched naloxone nasal spray, 4mg/0.1mL, a generic to the OTC version of Narcan. Although the cost for Amneal’s product is not yet available, other OTC naloxone products retail for about $45 per box.

Pediatric Indication Approved for Lutathera

The indication for Lutathera^® (lutetium Lu 177 dotate) injection was expanded by the FDA on April 23, 2024, to include patients as young as 12 years old. The radioactive analog of somatostatin treats gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that are somatostatin receptor-positive. Formerly called gastrointestinal (GI) carcinoid tumors, GEP-NETs are a group of tumor types that are estimated to affect about 8,000 new patients per year in the U.S. Usually slowly progressing tumors, they are hard to diagnose because their symptoms, which are similar to those of other abdominal conditions, vary widely depending on the affected tissue. Lutathera contains a peptide that targets cancer cells and a radioactive element. The peptide part sticks to somatostatin receptors on tumor cells and then invades the cells where the radiation damages the cancer’s DNA beyond repair. Given by intravenous (IV) infusions, the recommended dosing is one vial (7.4GBq/200mCi) once every eight weeks for four cycles. Lutathera must be administered by physicians who are trained and authorized to give radiopharmaceuticals and in facilities that are equipped to minimize exposure to radiation. For revised prescribing information, go here.

Labeling Change for Biktarvy

Gilead Sciences got FDA approval on April 24, 2024, to include new clinical trial information on the labeling for Biktarvy^® (bictegravir/emtricitabine/tenofovir alafenamide) tablets. It already is FDA-approved as a first line to treat HIV-1 infection for adults and pediatric patients who weigh at least 14kg (about 30 pounds). It also is indicated to replace the current antiretroviral (ARV) regimen in patients who maintain virological suppression (less than 50 copies of HIV-1 RNA/mL) on a stable ARV regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. Gilead now can call out Biktarvy’s effectiveness and safety for pregnant women living with HIV. Study 5310 enrolled women who took Biktarvy once a day beginning in their second or third trimesters of pregnancy and lasting until 18 weeks after the birth. Viral suppression was sustained for all 32 participants and no HIV infection was passed to any of the 29 infants who were born during the trial. Guidelines from the U.S. Department of Health and Human Services (HHS) recommend Biktarvy as one drug regimen for women who have HIV and who are trying to conceive a baby or who are pregnant. A boxed warning cautions about using Biktarvy for patients who have both HIV and hepatitis B (HBV) because HBV may re-emerge when treatment is stopped. Check here for updated prescribing information.

Recall On April 23, 2024, Dr. Reddy’s announced a recall of six lots for Javygtor^™ (sapropterin) 100mg powder for oral solution and their generic version of sapropterin 100mg powder for oral solution. The recall is to the consumer level due to discolored powder in some packets that may also have decreased potency. Since the drug is indicated to reduce blood phenylalanine (Phe) in patients, reduced efficacy of the drug could lead to elevated phenylalaninemia levels. This could potentially lead to permanent neurocognitive effects in infants or children. Elevated levels of Phe in pregnant patients can also lead to complications such as early gestation, microcephaly, and congenital heart disease. For more information see here.