Apadamtase alfa /Cinaxadamtase alfa

近期，美国食品药品监督管理局（FDA）对武田制药的药物Adzynma展开了安全调查，原因是有儿童患者在使用该药物后出现了死亡的报告。Adzynma获批用于治疗一种罕见的血液疾病——先天性血栓性血小板减少性紫癜。FDA的调查主要集中在患者是否产生了针对药物成分ADAMTS13的中和抗体。虽然武田制药表示目前尚未确认二者之间的因果关系，但这一事件无疑引发了公众对药物安全性的关注。与此相对的是，Otsuka制药公司最近获得了FDA对其新药Voyxact的加速批准。这是一种用于治疗IgA肾病的生物药物，Voyxact是首个通过FDA批准的能够阻断APRIL蛋白的药物。根据临床试验数据，Voyxact在九个月内能够显著减少51%的蛋白尿，这在当前竞争激烈的肾病治疗市场中无疑具有重要的突破性意义。在药物研发的另一条战线上，Daiichi Sankyo在与Pfizer的Seagen之间的抗体药物结合物（ADC）专利争斗中取得了胜利。美国联邦巡回上诉法院推翻了之前对Daiichi不利的判决，认为其并未侵犯Seagen的专利。这一判决不仅为Daiichi Sankyo扫清了障碍，也为ADC的研发和市场竞争注入了新的活力。抗体药物结合物（ADC）是近年来药物研发的热门领域，结合了单克隆抗体的靶向性和化疗药物的杀伤力，能够更精准地攻击癌细胞。ADC的成功研发，不仅依赖于生物技术的进步，也需要对癌症生物学的深入理解。随着技术的不断发展，ADC未来有望在多种类型的癌症治疗中发挥更大的作用。在临床应用中，患者使用新药时常常会有各种顾虑，尤其是安全性和副作用。对于Adzynma的事件，患者应当关注药物的使用说明和医生的建议，特别是在用药过程中如有异常反应，应及时与医疗专业人员沟通。同时，对于新获批的Voyxact，患者也需要了解可能的副作用，并在使用前与医生进行详细的讨论。总的来说，FDA的调查、Otsuka的新药批准以及ADC的专利争斗，都是当前药物研发和使用中的重要事件。它们不仅影响着制药公司的市场策略，更直接关系到患者的治疗选择和安全。作为普通患者，我们应当保持对新药的关注，并积极参与与医生的沟通，以确保自身的用药安全。注：本文内容仅供科普参考，不构成专业医疗建议，如有健康问题请咨询专业医生。返回搜狐，查看更多

An FDA safety probe into Takeda's Adzynma, Otsuka's IgAN approval for Voyxact and Daiichi Sankyo's latest win against Pfizer made our news this week. The FDA is investigating a safety signal from Takeda’s rare disease med Adzynma. Otsuka won a first-in-class FDA approval to enter the crowded IgA nephropathy field. Daiichi Sankyo won reversal of an unfavorable ruling in its patent fight against Pfizer’s Seagen. And more.1. FDA launches investigation into Takeda's Adzynma following reported pediatric deathThe FDA is investigating Takeda’s Adzynma following a reported child's death. The drug, approved for the rare blood disorder congenital thrombotic thrombocytopenic purpura, is under scrutiny due to postmarketing reports of patients developing neutralizing antibodies against the drug’s ADAMTS13 protein ingredient. Takeda said it found no confirmed causal link.2. In crowded kidney disease space, Otsuka receives FDA approval for first-in-class VoyxactOtsuka received accelerated FDA approval for Voyxact (sibeprenlimab) to treat IgA nephropathy (IgAN). The monthly self-administered drug is the first biologic cleared for the kidney disease and the first to block the APRIL protein. Before entering a competitive market, Voyxact showed a placebo-adjusted 51% reduction in proteinuria at nine months in a phase 3 trial.3. Daiichi Sankyo prevails on appeal in long-running ADC patent battle with Seagen, flipping prior $41.8M verdictDaiichi Sankyo got a win in its long-running antibody-drug conjugate patent dispute with Pfizer’s Seagen. The U.S. Court of Appeals reversed a prior ruling that found Daiichi infringed a Seagen patent with Enhertu. The new decision nullifies a previous Texas court verdict, which said Daiichi owed Seagen royalties related to the popular ADC.4. Crescent waxes pipeline with $80M Kelun deal, bagging ADC to pair with PD-1xVEGF bispecificCrescent Biopharma struck a $80 million upfront deal for ex-China rights to Kelun-Biotech’s integrin beta-6-directed ADC candidate. Crescent plans to test the new ADC in combination with its own PD-1xVEGF bispecific antibody for solid tumors. In exchange, Kelun will pay $20 million upfront for Chinese right to Crescent’s bispecific. 5. Merck's partner Kelun touts phase 3 win for ADC-Keytruda combo in first-line lung cancerKelun also reported a phase 3 win for its Merck & Co.-partnered TROP2 ADC, sacituzumab tirumotecan (sac-TMT), combined with Keytruda. The combo significantly improved progression-free survival versus Keytruda alone in Chinese patients with first-line PD-L1-positive non-small cell lung cancer, according to Kelun.6. FDA grants game-changing perioperative approval to Padcev, Keytruda combo in bladder cancerA combination of Astellas and Pfizer’s Padcev and Keytruda won an FDA approval as a perioperative treatment for muscle-invasive bladder cancer patients ineligible for cisplatin chemotherapy. The regimen, used around surgery, is the first to significantly improve survival over surgery alone in this population, reducing the risk of death by 50% in a phase 3 trial.7. Daiichi Sankyo receives FDA untitled letter taking aim at Turalio patient ambassador videoSK Life Science Xcopri ad meets a roadblock with FDA untitled letterThe FDA issued separate untitled letters to Daiichi Sankyo and SK Life Science over “false or misleading” drug marketing. The letter to Daiichi cited a Turalio patient ambassador video that overstated treatment benefits, while the letter to SK Life Science took aim at a TV ad for the anti-seizure drug Xcopri for omitting major risk warnings and failing to present risk information concurrently in both audio and text.Other News of Note: 8. FDA floats user fee cuts for early-stage US trials, additional fees for overseas development9. After dodging Biosecure threat, WuXi AppTec faces new security scrutiny from Pentagon: Bloomberg10. Tanabe Pharma shifts gears for Bain-backed future, dropping Mitsubishi moniker after $3.3B deal11. Sun Pharma shines a light on diabetic retinopathy in #SeeBeyondSugar campaign12. Pfizer, GSK, Shionogi sponsor London run of musical about antimicrobial resistance13. Eisai finalizes FDA filing for subcutaneous Leqembi starter dose (Regulatory tracker)14. China launches national drug price registration system (Yicai)