FDA Updates for Week of March 4, 2024: Wegovy Gets New Indication

FDA Approves Additional Indication for Wegovy

The FDA has approved an additional indication for Wegovy (semaglutide): to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight.

The approval is based on the SELECT cardiovascular outcomes trial, which demonstrated that Wegovy statistically significantly reduced the risk of MACE by 20% compared with placebo when added to standard of care. In the SELECT trial Wegovy 2.4 mg reduced the risk of major adverse cardiovascular events. The trial enrolled 17,604 adults aged 45 years or older with obesity and established cardiovascular disease with no prior history of diabetes. These results were released at the American Heart Association Scientific Session meeting in November 2023. The label for Wegovy has been updated to include data from SELECT.

Wegovy 2.4 mg, developed by Novo Nordisk, was approved first to treat obesity in adults. It has a list price of $1,349.02 per package, which is a 28-day supply. Novo Nordisk also markets a lower-dose version of semaglutide as Ozempic to treat patients with diabetes. It is available in 0.5 mg, 1.0 mg and 2.0 mg doses. The list price for Ozempic 1.0 mg is $935.77 for one pen.

FDA Approves Second Biosimilar of Actemra

The FDA has approved Fresenius Kabi’s Tyenne (tocilizumab-aazg), its tocilizumab biosimilar referencing Genentech’s Actemra. It was approved to treat patients with several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

The approval is based on analytical similarity and clinical data used to demonstrate similar pharmacokinetic, efficacy, safety, tolerability, and immunogenicity to the reference product, with and without switch from Actema to Tyenne.

Tyenne has launched globally in more than 10 countries. But Fresenius Kabi officials indicated in a press release that the launch date in the United States depends on a patent settlement agreement with Genentech, which is confidential.

It could be a crowded market when Tyenne launches. Although not the first biosimilar approved to reference Actemra, Tyenne is the first to have both IV and subcutaneous options approved by the FDA. In September 2023, the FDA approved Biogen’s IV formulation biosimilar, Tofidence. Tofidence is not yet available on the U.S. market.

Tyenne, Tofidence and Actemra are interleukin-6 (IL-6) receptor antagonists that target specific inflammatory proteins to suppress the immune system.

Additionally, in January 2024, Celltrion USA completed its biologic license application to the FDA for CT-P47, its Actemra biosimilar. Celltrion is seeking approval for CT-P47 in both intravenous and subcutaneous formulations.

FDA Approves First Prolia, Xgeva Biosimilars

The FDA has approved the first biosimilars for denosumab that reference Amgen’s osteroporisis drug Prolia and the bone cancer drug Xgeva. Developed by Sandoz, both biosimilars are interchangeable with the reference products for all indications.

Wyost (denosumab-bbdz) is approved to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. It is also approved to treat adults and skeletally mature adolescents with giant cell tumor of bone and hypercalcemia of malignancy refractory to bisphosphonate therapy.

Jubbonti (denosumab-bbdz) is approved to treat several conditions, including men and postmenopausal women with osteoporosis. It is also approved to treat glucocorticoid-induced osteoporosis in men and women, to increase bone mass in men receiving androgen deprivation therapy for nonmetastatic prostate cancer, and for women receiving adjuvant aromatase inhibitor therapy for breast cancer.

Wyost and Jubbonti have the same dosage form, route of administration, dosing regimen as the reference medicines. Sandoz, however, would not comment on when Wyost and Jubbonti will be available. Patent litigation around these products is ongoing.

FDA to hold Advisory Committee on Donanemab in Alzheimer’s Disease

The FDA plans to hold a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to discuss the phase 3 trial of Lilly’s donanemab in early symptomatic Alzheimer's disease.

Regulators said they want to discuss the safety results in donanemab-treated patients and the efficacy implications of the unique trial design of the TRAILBLAZER-ALZ 2 study. Specifically they want to discuss the trial’s use of limited-duration dosing regimen that allowed patients to complete treatment based on an assessment of amyloid plaque and the inclusion of participants based on tau levels.

Donanemab was under review for full approval to treat patients with early Alzheimer’s disease. A decision had been expected by the end of 2023. The FDA had previously said it wouldn’t grant accelerated approval of donanemab to treat patients with early Alzheimer’s disease. In a complete response letter in January 2023, the agency indicated that there too few patients with at least 12 months of data provided in Lilly’s submission. Lilly had resubmitted the application in July 2023 for full approval

Full results from the trial show that donanemab slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease. Almost half of participants at earlier stage of disease on donanemab had no clinical progression at one year. Additionally, analyses of patients at earliest stage of the disease had even greater benefit, with 60% slowing of decline compared with placebo.

The data were shared at the 2023 Alzheimer’s Association International Conference and also published in the Journal of the American Medical Association.