JAZZ PHARMACEUTICALS FRANCE

Avadel Pharmaceuticals' LUMRYZ received a favorable court ruling affirming FDA approval, despite Jazz Pharmaceuticals' challenge under the Orphan Drug Act. LUMRYZ, the only once-at-bedtime oxybate treatment for narcolepsy, was also approved for pediatric use and demonstrated efficacy in clinical trials. Avadel anticipates operating income in Q3 2024, with analysts projecting over $600 million in sales by 2030. A study found 94% of participants preferred LUMRYZ over twice-nightly treatments.

A D.C. federal judge upheld the FDA's determination that a rival narcolepsy treatment is not the 'same drug' as Jazz Pharmaceuticals' exclusive treatment, ruling the FDA's approval did not violate the Orphan Drug Act.

Recent advancements in HCC and BTC treatment include targeted therapy combinations like atezolizumab plus bevacizumab for HCC and durvalumab with gemcitabine and cisplatin for BTC, improving survival outcomes. Liquid biopsies and precision medicine are also transforming early detection and treatment options.

FDA approves Avadel's Lumryz for narcolepsy in children aged 7 and older, offering a once-nightly treatment option. Lumryz, already approved for adults, is superior to Jazz Pharmaceutical's Xyrem and Xywav due to its dosing regimen, which does not require middle-of-the-night administration.

Study on MM treatment decision-making highlights QoL, duration of response, and side effects as top attributes for patients, care partners, and physicians. Differences in preferences and trade-offs underscore the importance of shared decision-making (SDM) to align treatment plans with patient values and improve outcomes.

Lurbinectedin plus atezolizumab improved survival outcomes in extensive-stage small cell lung cancer patients, prompting a planned sNDA submission for first-line maintenance therapy by 2025.

Bio-pharma advances in endocrinology, dermatology, cardiovascular, oncology, rare diseases, pulmonology, gastroenterology, and neurology highlight promising therapies like Eli Lilly’s orforglipron, Amgen’s MariTide, Novo Nordisk’s oral semaglutide, Johnson & Johnson’s JNJ-2113, Sanofi’s amlitelimab, Ionis’s olezarsen, BridgeBio’s acoramidis, NewAmsterdam Pharma’s obicetrapib, Jazz Pharmaceuticals’ zanidatamab, Syndax’s revumenib, Merus’ zenocutuzumab, Johnson & Johnson’s nipocalimab, Novo Nordisk’s Mim8, Solid Biosciences’ SGT-003, Merck’s sotatercept, Johnson & Johnson’s Tremfya, and Crossject’s Zepizure, with analyses including clinical data, revenue forecasts, and expected launch dates.

Jazz Pharmaceuticals' Zepzelca (lurbinectedin) plus Roche's Tecentriq (atezolizumab) showed significant improvement in overall and progression-free survival in extensive-stage small cell lung cancer (SCLC) maintenance treatment, with safety consistent with known profiles. Jazz plans to submit a supplemental new drug application for this combination in the first half of 2025.