GLP-1s get expanded indication, new generic

Recalls and warnings

A class I recall updating use instructions for Boston Scientific's POLARx and POLARx FIT cryoablation balloon catheters due to a higher than anticipated number of reports of esophageal injury, specifically atrio-esophageal fistula, after catheter ablation procedures for atrial fibrillation. The use of affected products may cause serious consequences, including atrio-esophageal fistula leading to cerebral air embolism, gastrointestinal bleeding, septic shock, and death. There have been seven injuries and four deaths reported.

An alert about a recommendation that the forceps/irrigation plug accessory to certain Olympus endoscopes be removed from use. The alert includes all lots of the MAJ-891 forceps/irrigation plug (isolated type), based on reports of 120 injuries and one death due to infection following procedures in which the device was used with a cystoscope.

An alert about updated use instructions for certain endoscope sheaths from Trokamed. The previous instructions for use provided with the device did not clearly describe that the sheath is not to be used for suction and irrigation. One death has been reported to be associated with this issue.

An update to a prior drug safety communication adding a boxed warning about the risk of serious liver injury with use of fezolinetant (Veozah), a drug indicated to treat hot flashes caused by menopause.

A class I recall of disposable biopsy needle kits used with the Leksell stereotactic system by Elekta due to a risk for microscopic debris on the inside of the biopsy needle that could enter the brain tissue. The sterility of the biopsy needles has not been affected. There have been no reported injuries or deaths.

A class I recall of MicroTargeting insertion tube sets from lot 244517 after a manufacturing error caused the reducing cannula in these sets to be 20 mm longer than specified. There have been no reported injuries or deaths.

A class I recall of certain lots of Monoject U-100 1-mL insulin syringe luer-lock with tip cap soft packs by Cardinal Health, due to an incompatibility with needleless IV connectors. Use with a needleless connector may increase the risk that the patient may not receive the full dose of insulin.

A drug safety communication warning of cases of serious liver injury among patients being treated for primary biliary cholangitis with obeticholic acid (Ocaliva) who did not have cirrhosis of the liver. The FDA is notifying clinicians that frequent liver test monitoring is necessary to identify worsening liver function and ensure appropriate discontinuation of the treatment. Based on the current data, it is not clear if this monitoring will be sufficient to address the risk of serious liver injury, the FDA noted. Treatment should be discontinued if there is any evidence of liver disease progression or if efficacy is not established.

A safety communication about the potential need for early device replacement of Boston Scientific Corporation Accolade pacemaker devices, which include the Accolade, Proponent, Essentio, and Altrua 2 Standard Life and Extended Life pacemakers and the Visionist and Valitude cardiac resynchronization therapy pacemakers. The manufacturer recalled a subset of Accolade pacemaker devices due to an increased risk of permanently entering safety mode, which has limited functionality.

Approvals

A new indication for tirzepatide (Zepbound) for the treatment of moderate to severe obstructive sleep apnea in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity. Approval is based on two randomized placebo-controlled studies finding a statistically significant and clinically meaningful reduction in events of apnea or hypopnea compared with placebo. Side effects include nausea, diarrhea, and vomiting, among others.

Concizumab-mtci (Alhemo) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. Efficacy and safety were evaluated in 91 adult and 42 adolescent male patients with hemophilia A or B with inhibitors who had been prescribed, or were in need of, treatment with therapies that bypass the inhibitor effect. A ratio of the annualized bleeding rates was estimated to 0.14, corresponding to a reduction of 86% for the treatment group compared to the no prophylaxis group. The most common adverse reactions included injection site reactions and hives. The treatment received an orphan drug designation.

Olezarsen (Tryngolza) to reduce triglycerides in adults with familial chylomicronemia syndrome in combination with diet. This is a first-in-class approval. The most common adverse reactions were injection site reactions, decreased platelet count, and arthralgia.

Symvess, the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. This is a one-time, single-use product surgically implanted to replace a patient's damaged blood vessel after a traumatic injury to the extremity. Safety and efficacy were evaluated in a prospective nonrandomized trial in which 54 patients with life- or limb-threatening vascular trauma received the new product. Of these, 36 retained primary patency and 39 retained secondary patency at day 30. Five patients underwent amputation of the treated limb within the first 30 days and eight patients had by month 36. Common adverse reactions include thrombosis, fever, pain, and anastomotic stenosis.

Acoramidis (Attruby) to treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis. Efficacy and safety were evaluated in 611 patients. At 30 months, more patients taking acoramidis versus placebo were alive (81% vs. 74%) and there were fewer cardiovascular-related hospitalizations in those taking acoramidis versus placebo (mean, 0.3 vs. 0.6 per year). Common adverse reactions included diarrhea and upper abdominal pain. The treatment received an orphan drug designation.

Crinecerfont (Crenessity) to be used with glucocorticoids to control androgen levels in adults and pediatric patients ages four years and older with classic congenital adrenal hyperplasia (CAH). Approval is based on two randomized controlled trials in 182 adults and 103 children with classic CAH. Adult patients who received crinecerfont reduced their daily glucocorticoid dose by 27% while maintaining control of androstenedione levels, compared to a 10% daily glucocorticoid dose reduction in the group that received a placebo. The treatment received an orphan drug designation and carries a warning for acute adrenal insufficiency or adrenal crisis. Common side effects included fatigue, dizziness, and arthralgia.

Marketing authorization of Lungpacer Medical USA, Inc.'s, AeroPace system, a temporary diaphragm activation system placed with a catheter to improve ventilator weaning success in patients 18 years of age or older. The system stimulates the phrenic nerves, activating the diaphragm to maintain its strength to improve the patient's ability to wean from a ventilator. The system previously received a breakthrough device designation and is intended for patients who have been on a mechanical ventilator for at least 96 hours and have not yet weaned.

Marketing authorization of Sequana Medical NV's alfapump system, an implanted pump indicated for the removal of excess peritoneal fluid in certain adult patients experiencing fluid buildup in the abdominal cavity due to liver cirrhosis.

First-time generic drug approvals

The first generic version of liraglutide injection, 18 mg/3 mL, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients ages 10 years and older with type 2 diabetes as an adjunct to diet and exercise. The treatment includes a boxed warning to advise health care professionals and patients about the increased risk of thyroid C-cell tumors. (Brand name: Victoza) The FDA approved the first generic in this class of medications with the approval of a generic for exenatide. (Brand name: Byetta)

Note: The FDA states that drugs are not always commercially available immediately after approval.