Capital Rx
Highlights
- Four key new drug approvals, including Duvyzat™ (givinostat) for Duchenne muscular dystrophy
- Eleven (11!) notable expanded indications, including Wegovy® (semaglutide) for use to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight
- Four Biosimilar approvals
- Two generic launches
- Capital Rx's Updated 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, as well as products in the pipeline. Read on to review our March 2024 Monthly Drug Update!
Key New Drug Approvals
Rezdiffra™ (resmetirom) tablet
Approval Date: 03/14/2024 - CLICK HERE for the press release
Indication: Noncirrhotic nonalcoholic steatohepatitis with moderate to advanced liver fibrosis
Cost*: $47,100 annually
Key Considerations:
- First and only treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis, in conjunction with diet and exercise
- Granted accelerated approval
Tryvio™ (aprocitentan) tablet
Approval Date: 03/19/2024 - CLICK HERE for the press release
Indication: Hypertension
Cost*: TBD
Key Considerations:
- First and only endothelin receptor antagonist for the treatment of high blood pressure in combination with other antihypertensive drugs in adult patients
- Once daily administration to be taken with or without food
- Boxed warning of embryo-fetal toxicity and will be available through a Risk Evaluation Mitigation Strategy (REMS) program only
Duvyzat™ (givinostat) oral suspension
Approval Date: 03/21/2024 - CLICK HERE for the press release
Indication: Duchenne muscular dystrophy
Cost*: $350,000 annually
Key Considerations:
- First nonsteroidal oral medication approved for the treatment in patients 6 years of age and older who have all genetic variants of Duchenne muscular dystrophy
- Launch will occur in the U.S. approximately Q3 of 2024
Opsynvi® (macitentan/tadalafil) tablet
Approval Date: 03/22/2024 - CLICK HERE for the press release
Indication: Pulmonary arterial hypertension
Cost*: TBD
Key Considerations:
- First and only once-daily single tablet combination therapy in patients with pulmonary arterial hypertension
- Boxed warning due to the risk of embryo-fetal toxicity and requires female patients to enroll in the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS) program
Notable Expanded Indications
Xhance® (fluticasone propionate) nasal spray- expanded to be used for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older
Wegovy® (semaglutide) subcutaneous injection- expanded to be used to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight
Breyanzi® (lisocabtagene maraleucel) intravenous injection- expanded to be used for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor
Praluent® (alirocumab) subcutaneous injection- expanded to be used as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies in patients 8 years of age and older with heterozygous familial hypercholesterolemia
Brukinsa® (zanubrutinib) capsule- expanded to be used for the treatment of relapsed or refractor follicular lymphoma
Livmarli® (maralixibat) oral solution- expanded to be used for the treatment of pruritus in progressive familial intrahepatic cholestasis
Spevigo® (spesolimab-sbzo) subcutaneous injection- expanded to be used for the acute and chronic treatment of generalized pustular psoriasis in adults and pediatric patients 12 years of age and older weight at least 40kg
Iclusig® (ponatinib) tablet- expanded to be used for the treatment in adult patients with newly diagnosed Philadelphia chromosome positive acute lymphocytic leukemia
Elahere® (mirvetuximab soravtansine-gynx) intravenous injection- expanded to be used for the treatment in adult patients with folate receptor-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
Ultomiris® (ravulizumab-cwvz) intravenous injection- expanded to be used for the treatment of adults with neuromyelitis optica spectrum disorder
Opdivo® (nivolumab) intravenous injection- expanded to be used in combination with cisplatin and gemcitabine for unresectable or metastatic urothelial carcinoma
Biosimilar Approvals
Simlandi® (adalimumab-ryvk) subcutaneous injection
Approval Date: 02/24/2024 - CLICK HERE for the press release
Indication: Adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa, and adult uveitis
Additional information:
- First interchangeable biosimilar to high concentration, citrate-free Humira®
- Launch timeline is expected in the first half of 2024 by the manufacturer, Teva/Alvotech
Jubbonti® (denosumab-bbdz) subcutaneous injection
Approval Date: 03/05/2024 - CLICK HERE for the press release
Indication: Treatment of postmenopausal women with osteoporosis at high risk for fracture, treatment to increase bone mass in men with osteoporosis at high risk for fracture, treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
Additional Information:
- Interchangeable biosimilar referencing Prolia®
- Boxed warning regarding the risk of severe hypocalcemia in patients with advanced kidney disease
- REMS program to inform patients and prescribers regarding the risk of severe hypocalcemia
Wyost® (denosumab-bbdz) subcutaneous injection
Approval Date: 03/05/2024 - CLICK HERE for the press release
Indication: Prevention of skeletal-related events in certain cancer patients; giant cell tumor or hypercalcemia of malignancy refractory to bisphosphonate therapy
Additional Information:
- Interchangeable biosimilar referencing Xgeva®
Tyenne® (tocilizumab-aazg) intravenous/subcutaneous injection
Approval Date: 03/05/2024 - CLICK HERE for the press release
Indication: Rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, or systemic juvenile idiopathic arthritis
Additional Information:
- Biosimilar referencing Actemra®
- First tocilizumab biosimilar with an intravenous and subcutaneous formulation
Generic Launches
Rectiv® (nitroglycerin 0.4%) ointment
Thiola EC® (tiopronin 100mg, 300mg) delayed-release tablet
Contact Us if you'd like to learn more about Capital Rx's full-service pharmacy benefit management (PBM) solutions and clinical programs.
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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