- Three key new approvals, including Inpefa™ (sotagliflozin), Vevye™ (cyclosporine), and Lodoco® (colchicine).
- Several notable expanded indications, including Linzess® (linaclotide), Lynparza® (olaparib), and Jardiance® (empagliflozin), among others.
- Two generic launches: Prezista® and Noxafil®
- Update Drug Recall Report: CLICK HERE to review.
Capital Rx's Clinical Team closely monitors the drug landscape to provide our clients with timely information on newly FDA-approved medications and products in the pipeline. Read on to review our June 2023 Monthly Drug Update!
Key New Drug Approvals
Inpefa™ (sotagliflozin) tablets
Approval Date: 05/26/2023 - CLICK HERE for the press release
Indication: Reduce the risk of cardiovascular death, hospitalization for certain patients with heart failure
Cost*: $24 per tablet
- First SGLT-1/SGLT-2 inhibitor, once-daily oral tablet to reduce the risk of cardiovascular disease, hospitalization for heart failure, and urgent heart failure visits in adults with type 2 diabetes, chronic kidney disease, and other cardiovascular risks
- Granted broad label to encompass heart failure patients across the full range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, and for patients with or without diabetes
Vevye™ (cyclosporine) ophthalmic solution
Approval Date: 05/30/2023 - CLICK HERE for the press release
Indication: Signs and symptoms of dry eye disease
- Approved via the 505b2 pathway using the reference product Restasis®
- Water-free ophthalmic solution formulation of the calcineurin inhibitor immunosuppressant for anti-inflammatory treatment of signs and symptoms of dry eye disease
Lodoco® (colchicine) tablets
Approval Date: 06/20/2023 - CLICK HERE for the press release
Indication: Reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease
- First anti-inflammatory medication approved for cardiovascular disease administered as a once-daily oral tablet
- Administered alone or in combination with cholesterol-lowering medications
- Available for prescription in the second half of 2023
Notable Expanded Indications
Linzess® (linaclotide) - expanded to be indicated for the treatment of functional constipation in children and adolescents 6 to 17 years of age
Bylvay™ (odevixibat) - expanded to be indicated for the treatment of cholestatic pruritis in patients aged 12 months and older with Alagille syndrome
Lynparza® (olaparib) - expanded to be used in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer
Jardiance® (empagliflozin) - expanded to be indicated in addition to diet and exercise to improve blood sugar control in children 10 years of age and older with type 2 diabetes
Synjardy® (empagliflozin/metformin) - expanded to be indicated in addition to diet and exercise to improve blood sugar control in children 10 years of age and older with type 2 diabetes
Prezista® (darunavir 600mg, 800mg) tablet for treatment of HIV infections
Noxafil® (posaconazole 300mg/16.7mL) IV solution to treat or prevent fungal infections
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* Cost: actual patient out-of-pocket costs may be lower, as the list price does not reflect insurance coverage, co-pay support for eligible patients, or financial assistance from patient support