Rx Insights from May '26

This month's edition provides a focused review of newly approved and recently launched therapies. Expion Health monitors these developments closely to assess clinical relevance, therapeutic positioning, and potential implications for payers, providers, and patients.

LANGLARA (insulin glargine-aldy)

Indication

LANGLARA is an FDA-approved biosimilar to Lantus indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. It has been designated as interchangeable with Lantus.

Dosage and Administration

Supplied as a 100 units/mL solution in a 3 mL prefilled pen for single-patient use. Administered subcutaneously once daily at the same time each day, with injection sites including the abdomen, thigh, or deltoid. Dosage should be individualized based on diabetes type, age, and clinical needs.

Warnings and Precautions

May cause serious adverse reactions including hypoglycemia, hypokalemia, rapid weight gain, peripheral edema, and shortness of breath. Patients should be monitored for blood glucose and potassium level changes. Healthcare providers should be informed if a patient is breastfeeding.

Mechanism of Action

A long-acting insulin analog providing steady basal insulin activity for 24 hours or longer following once-daily administration. Helps regulate blood glucose by facilitating cellular glucose uptake and suppressing hepatic glucose production.

Disease Background

Diabetes is a chronic, progressive metabolic disorder characterized by elevated blood glucose levels resulting from inadequate insulin production, impaired insulin action, or both. More than 40 million people in the United States are living with diabetes. Effective glycemic management is essential to reduce the risk of long-term complications affecting the cardiovascular, renal, neurologic, and visual systems.

Clinical Data

FDA approval was supported by a comprehensive biosimilar development program including analytical, preclinical, and clinical studies. The totality of evidence demonstrated pharmacokinetic, pharmacodynamic, efficacy, safety, and immunogenicity profiles highly similar to those of Lantus in patients with both type 1 and type 2 diabetes.

VEPPANU (vepdegestrant)

Indication: Treatment of adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease has progressed following at least one line of endocrine-based therapy.

Clinical Data: Based on the Phase 3 VERITAC-2 trial (n=624). In ESR1-mutated tumors, VEPPANU demonstrated a 43% reduction in the risk of disease progression or death compared with fulvestrant.

IMMGOLIS (golimumab-sldi)

Indication: A biosimilar to Simponi indicated for moderately to severely active rheumatoid arthritis and ulcerative colitis. Carries a Boxed Warning for serious infections and malignancies.

BAXFENDY (baxdrostat)

Indication: An aldosterone synthase inhibitor for hypertension not adequately controlled with current therapy. Phase 3 BaxHTN trial showed a placebo-adjusted systolic BP reduction of 9.8 mmHg at the 2 mg dose.

BEQALZI (sonrotoclax)

Indication: A BCL-2 inhibitor for relapsed/refractory mantle cell lymphoma after at least two prior lines of therapy including a BTK inhibitor. Overall response rate of 52%.

HEPCLUDEX (bulevirtide-gmod)

Indication: First-in-class antiviral for chronic hepatitis delta virus infection, blocking HDV/HBV entry into hepatocytes. Carries a Boxed Warning for severe acute exacerbations after discontinuation.

DECNUPAZ (pivekimab sunirine-pvzy)

Indication: A CD123-targeted antibody-drug conjugate for blastic plasmacytoid dendritic cell neoplasm (BPDCN). Composite complete response rate of 69.7% in newly diagnosed patients.