New Indication for Jardiance
Jardiance® (empagliflozin) tablets, a sodium-glucose co-transporter 2 (SGLT2) inhibitor marketed by Eli Lilly and Company and Boehringer Ingelheim, gained a new indication on Sept. 22, 2023. It now is U.S. Food and Drug Administration (FDA) approved to decrease the chances of persistent declines in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular (CV) death, and hospitalization for adults who have chronic kidney disease (CKD) that is likely to worsen. In a clinical study that involved more than 6,600 patients, those who were treated with Jardiance averaged a 28% decrease in the risk of disease progression and complications compared to participants randomly assigned to placebo. All enrollees kept taking their previous treatment for CKD during the trial. Originally approved in 2014 along with diet and exercise to improve glycemic control for adults who have type 2 diabetes, Jardiance later got indications to reduce CV death for patients who have both diabetes and CV disease, as well as for adults who have heart failure (HF) regardless of ejection fraction status. Additionally, its initial indication for type 2 diabetes has been extended to patients as young as 10 years old. The recommended dose for all of Jardiance’s indications is 10mg once each morning. AstraZeneca’s Farxiga® (dapagliflozin) tablets have a similar indication for patients who have CKD. Here is the current prescribing information for Jardiance.
As part of its Project Renewal program, the FDA has approved a new indication and modified a previous one for temozolomide. On Sept. 14, 2023, the alkylating agent was approved for use as an adjuvant to treat adult patients who are newly discovered to have anaplastic astrocytoma. Its prior approval for treating refractory anaplastic astrocytoma has been updated with new dosing recommendations. A third indication, initially in combination with radiation and then alone as maintenance, to treat newly diagnosed glioblastoma has not changed although dosing for it has been adjusted. Temozolomide is available generically as capsules in several strengths and as branded Temodar® (Merck) intravenous (IV) injection. Doses and schedules depend on the condition being treated. Warnings and patient counseling sections of the label have been updated, as well. Look here for revised prescribing information. Under Project Renewal, cancer experts and new clinicians who are independent of the FDA evaluate additional information, such as off-label uses, post-marketing studies, and real-world evidence, for cancer drugs that have been in use for extended periods. When justified, alterations to the drug’s prescribing information are made by the FDA to reflect the added data. More information about the project is here.
New Dosing Schedule for Talicia In a press release dated Sept. 18, 2023, RedHill Biopharma announced that the FDA has approved Talicia® (amoxicillin/rifabutin/omeprazole) capsules for mealtime dosing, with four capsules taken together three times daily for 14 days. Doses should be at least four hours apart. Previously, it was taken on a fixed schedule of once every eight hours. Containing a proton-pump inhibitor (PPI) and two antibacterial drugs, it is indicated for the short-term treatment of adults who have Helicobacter pylori (H. pylori) infections. Although several similar combination drugs are available, Talicia is the only one that contains rifabutin, an antimycobacterial drug more frequently used to treat tuberculosis (TB). By including rifabutin in Talicia, the manufacturer hopes to reduce the spread of bacterial resistance, which is increasing to more commonly used antibiotics. H. pylori bacteria are strongly associated with peptic ulcers and some forms of stomach cancer. According to Redhill, an estimated two million American adults are treated for H. pylori-related conditions, each year. Patients should not drink alcohol while using it, and Talicia should not be taken at the same time as the antifungal drug, voriconazole, or certain drugs used to treat HIV infections. Its revised prescribing information is here.