FDA Approves Orlynvah to Treat Urinary Tract Infections

On Oct. 25, 2024, the US Food and Drug Administration (FDA) approved Orlynvah^™ (sulopenem etzadroxil and probenecid – Iterum Therapeutics). This is an oral formulation of a penem antibiotic, sulopenem etzadroxil, and a renal tubular transport inhibitor, probenecid, indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. Uncomplicated UTIs are among the most common outpatient infections in the US, accounting for an estimated 10 million outpatient visits per year. This is the first oral penem approved in the US and offers an option for difficult-to-treat uUTIs. Two Phase III trials evaluated the safety and efficacy of Orlynvah, demonstrating effectiveness over ciprofloxacin in treating fluoroquinolone-resistant infection and demonstrating non-inferior and statistically superior to Augmentin (amoxicillin/clavulanate) in susceptible patients. The trials also showed that Orlynvah was generally well tolerated with the most common adverse reactions including diarrhea, nausea, headache, yeast infections, and vomiting. The recommended dose is one 500mg tablet orally, twice daily for five days with food. Iterum Therapeutics intends to launch Orlynvah in mid-2025. Full prescribing information may be found here.

Jylamvo Approval Expanded to Include Children

Shorla Oncology announced that the FDA expanded the approval of Jylamvo^® (methotrexate) oral solution on Oct. 29, 2024, to include the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA). Previously approved indications include treating adults who have ALL or non-Hodgkin’s lymphoma (NHL) in combination with other drugs and as monotherapy for the treatment of adults who have mycosis fungoides, rheumatoid arthritis (RA), or severe psoriasis. Numerous other injectable and oral methotrexate products are available in the United States; however, Jylamvo is the only liquid approved for both adults and children. Jylamvo is orange flavored and comes with a dedicated dosing syringe offering another option for patients who may have difficulty swallowing pills. It also remains stable at room temperature for 90 days after opening eliminating the need for refrigeration before dispensing. Here is the prescribing information.

RoxyBond 10mg Tablets Approved

The FDA has approved Protega Pharmaceutical’s RoxyBond^™ (oxycodone hydrochloride) immediate-release CII 10mg tablet on Oct. 29, 2024. RoxyBond is indicated for the treatment of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is formulated with SentryBond^™ abuse-deterrent technology which reduces potential abuse by intranasal and intravenous routes. It still may be misused through ingestion, inhalation, or intravenous (IV) administration, however. Labels for all opioids, regardless of their abuse-deterrent properties, have a boxed warning that taking them may be associated with abuse, addiction, misuse, overdose, and death. Doses of 5mg, 15mg, and 30mg have been available since 2017; Protega plans to launch 10mg by year-end. For prescribing information, click here.

New Indication for Scemblix

On Oct. 29, 2024, Novartis announced the FDA has granted accelerated approval to Scemblix^® (asciminib) for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP). Originally approved in 2021 as a third-line treatment, Scemblix is the first drug in a new class called STAMP inhibitors, it blocks the ABL myristoyl pocket. The Phase III trial showed a 67.7% major molecular response rate (MMR) at 48 weeks, which is 19% higher MMR than standard-of-care tyrosine kinase inhibitors (TKIs) and Gleevec^® (imatinib). The trial also demonstrated a similar safety profile with prior studies and fewer treated-related grade 3 or higher adverse events when compared to imatinib and TKIs. Due to its Accelerated Approval, the indication as first-line treatment will not be converted to full approval until further clinical trial results prove its durability of response and survival outcomes, estimated in early 2028. For full prescribing information, please click here.

Zulresso Being Discontinued

Sage Therapeutics announced that it will discontinue Zulresso^® (zuranolone) and not pursue further development in major depressive disorder (MDD). This was a business decision that came after the FDA rejected zuranolone in MDD last year. Originally approved in 2019, this was the first drug specifically indicated to treat postpartum depression (PPD). It is a neuroactive steroid gamma-aminobutyric acid (GABA)A receptor-positive modulator that partially stimulates GABAA receptors in the brain. Only available at registered medical facilities, Zulresso is given by trained healthcare providers as an IV infusion over 60 hours at dosage rates that increase to 90mcg/kg/hr and then taper back down. Sage states that the Zulresso will be available through the end of the year. Patients who need more information should contact the physician who prescribed Zulresso.

Recall

Cinacalcet Recall On Oct. 9, 2024, Dr. Reddy’s recalled all lots and expiration dates for cinacalcet 30mg, 60mg and 90mg tablets. The recall is due to the higher-than-allowed presence of the drug impurity nitrosamine. Since nitrosamine has the potential to cause cancer at higher doses when used over extended periods, the manufacturer has issued a recall for all lots in distribution. Cinacalcet is used to treat secondary hyperparathyroidism in patients who have chronic kidney disease on dialysis, hypercalcemia in patients who have parathyroid carcinoma, and severe hypercalcemia in patients who have primary hyperparathyroidism who cannot undergo parathyroidectomy. For more information, see here.