TYENNE

FDA Approves Tyenne (tocilizumab-aazg), a Biosimilar to Actemra

Fresenius Kabi, announced today that the U.S. Food and Drug Administration (FDA) has approved Tyenne® (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra® (tocilizumab). Tyenne becomes the first tocilizumab biosimilar with both IV and subcutaneous formulations approved by the FDA. In accordance with its patent settlement agreement with Genentech, Fresenius Kabi has a license to market its tocilizumab products in the U.S. commencing on the license dates, which are confidential.

Tyenne has launched globally in more than 10 countries, with plans to launch in many more countries between 2024 and 2025. Tyenne (tocilizumab-aazg) is FDA approved for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

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JUBBONTI

FDA Approves Jubbonti (denosumab-bddz), an Interchangeable Biosimilar to Prolia

Sandoz, has announced that the U.S. Food and Drug Administration approved Jubbonti, (denosumab-bbdz), an interchangeable biosimilar to Prolia.

Jubbonti is approved to:

• Treat postmenopausal women with osteoporosis at high risk for fracture.

• Increase bone mass in men with osteoporosis at high risk for fracture.

• Treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture.

• Increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.

• Increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.


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WYOST

FDA Approves Wyost (denosumab-bddz), an Interchangeable Biosimilar to Xgeva

Sandoz, announced that the U.S. Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz), an interchangeable biosimilar to Xgeva. Wyost is approved to prevent skeletal-related events (SREs) in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

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DEFINITY®

Lantheus Announces the FDA Approval of Definity (Perflutren Lipid Microsphere) for Pediatric Patients
Lantheus Holdings, Inc, has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Definity® (Perflutren Lipid Microsphere) as an ultrasound enhancing agent for use in pediatric patients with suboptimal echocardiograms. This approval represents a significant step forward in pediatric medicine, providing healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border. Currently, Definity is the most utilized, extensively studied, and a trusted diagnostic ultrasound enhancing agent in the U.S.

Clinical studies have substantiated the efficacy and safety of Definity in pediatric patients.

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RYBREVANT®

Rybrevant® in Combination with Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Johnson & Johnson has announced that following a priority review, the U.S. Food and Drug Administration (FDA) has approved Rybrevant® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test. This FDA action converts the May 2021 accelerated approval of Rybrevant® to a full approval based on the confirmatory Phase 3 PAPILLON study.

Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases. Alterations in EGFR are the most common actionable driver mutations in NSCLC. Clinical data show patients with EGFR exon 20 insertion mutations generally experience limited benefits with currently approved third-generation EGFR tyrosine kinase inhibitors and chemotherapy. NSCLC driven by EGFR exon 20 insertion mutations carries a worse prognosis and shorter survival rates compared with lung cancer driven by other EGFR driver mutations.

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LETYBO

FDA Approves Letybo (letibotulinumtoxinA-wlbg) for the Treatment of Glabellar Lines

Hugel America, Inc., a division of Hugel Inc., today announced it received U.S. Food and Drug Administration (FDA) approval on its neurotoxin, Letybo to treat moderate-to-severe glabellar (frown) lines in adults. In the coming months, Hugel plans to accelerate its transition for approved medical use with the goal of launching to aesthetic clinicians in the back half of 2024.

FDA approval is supported by positive results from three completed phase III trials that enrolled more than 1,000 subjects in the U.S. and Europe. This botulinum toxin type A has been the leading neurotoxin brand in South Korea, one of the world’s most dynamic aesthetic markets, for seven consecutive years. Hugel has sold over 26 million vials in 50+ different countries including Australia, Canada, and Europe.

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