[ad_1]
FDA approves additional indications for Wegovy
The FDA has approved an additional indication for Wegovy (semaglutide) to reduce the risk of cardiovascular death, heart attack, and stroke in obese or overweight adults with cardiovascular disease.
This approval is based on the SELECT cardiovascular outcomes trial, which demonstrated that Wegovy, when added to standard of care, reduced the risk of MACE by a statistically significant 20% compared to placebo. In the SELECT trial, Wegovy 2.4 mg reduced the risk of serious adverse cardiovascular events. The study enrolled 17,604 adults aged 45 and older with no history of diabetes, obesity and cardiovascular disease. These results were presented at the November 2023 American Heart Association Scientific Sessions Meeting. Wegovy’s labels have been updated to include data from SELECT.
Wegoby 2.4 mg, developed by Novo Nordisk, is the first drug approved to treat obesity in adults. List price is $1,349.02 per package with 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 doses of 0.5 mg, 1.0 mg, and 2.0 mg. Ozempic 1.0 mg list price is $935.77 per pen.
FDA approves second biosimilar of Actemra
The FDA has approved Fresenius Kabi’s Tian (tocilizumab-aazg), Fresenius Kabi’s tocilizumab biosimilar, which is based on Genentech’s Actemra. It has been 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.
This approval is based on the analytical similarities and immunogenicity used to demonstrate similar pharmacokinetics, efficacy, safety, tolerability, and immunogenicity to the reference product, with or without switching from Actema to Tyenne. Based on clinical data.
Tyenne has a global presence in more than 10 countries. However, Fresenius Kabi officials indicated in a press release that the U.S. release date 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 to be approved to refer to Actemra, Tienne is the first company to have both IV and subcutaneous delivery options approved by the FDA. In September 2023, the FDA approved Biogen’s IV biosimilar, Tofidence. Tofidence is not yet available in the US market.
Tyenne, Tofidence, and Actemra are interleukin-6 (IL-6) receptor antagonists that suppress the immune system by targeting specific inflammatory proteins.
Additionally, in January 2024, Celltrion USA completed a biologics license application to the FDA for its Actemra biosimilar, CT-P47. Celltrion is seeking approval for both intravenous and subcutaneous formulations of CT-P47.
FDA approves first Prolia, Xgeva biosimilar
The FDA has approved the first biosimilar of denosumab, based on Amgen’s osteoporosis drug Prolia and bone cancer drug Exgeva. Both biosimilars developed by Sandoz are compatible with the reference product for all indications.
Wyost (denosumab-bbdz) is approved for the prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors. It is also approved for the treatment of adults and skeletally mature adolescents with hypercalcemia of giant cell tumors of the bone and malignancies refractory to bisphosphonate therapy.
Jubbonti (denosumab-bbdz) is approved to treat several conditions, including men with osteoporosis and postmenopausal women. Also, treatment of glucocorticoid-induced osteoporosis in men and women, increased bone mass in men undergoing androgen deprivation therapy for non-metastatic prostate cancer, and bone mass in women undergoing adjuvant aromatase inhibitor therapy for breast cancer. It has also been approved for an increase in
Wyost and Jubbonti have the same dosage form, route of administration, and dosing regimen as the reference drug. However, Sand would not comment on when Wyost and Jubonti would be available. Patent litigation surrounding these products is ongoing.
FDA to convene advisory committee on donanemab in Alzheimer’s disease
The FDA will convene a meeting of its Peripheral Nervous System and Central Nervous System Drugs Advisory Committee to discuss the Phase 3 trial of Lilyz donanemab in early symptomatic Alzheimer’s disease.
Regulators said they would like to discuss the safety results in patients treated with donanemab and the efficacy implications of the TRAILBLAZER-ALZ 2 study’s unique study design. Specifically, we hope to discuss the use of time-limited dosing regimen trials that allow patients to complete treatment based on assessment of amyloid plaques, as well as participant enrollment based on tau levels.
Donanemab was under review for full approval to treat patients with early-stage Alzheimer’s disease. A decision was expected to be made by the end of 2023. The FDA previously said it would not grant early approval of donanemab to treat patients with early-stage Alzheimer’s disease. In a full response letter in January 2023, the agency noted that too few patients in Lilly’s submission provided at least 12 months of data.Lilly had resubmitted the application in July 2023 for full approval.
The full results of this trial show that donanemab slows cognitive function and functional decline in patients with early symptomatic Alzheimer’s disease. Almost half of the participants with early stage disease on donanemab had no clinical progression after 1 year. Additionally, there was an even greater benefit in an analysis of patients in the early stages of the disease, with a 60% slower decline compared to placebo.
This data will be shared at the 2023 Alzheimer’s Association International Conference. American Medical Association Journal.
[ad_2]
Source link