{"topic_id":"fda_nada_141_604_felycin_ca1_sirolimus_cat_hcm","category":"us-2026","context":"---\ntopic_id: fda_nada_141_604_felycin_ca1_sirolimus_cat_hcm\ncategory: us-2026\ntitle: FDA NADA 141-604 felycin-CA1 (Sirolimus Delayed-Release Tablets) — First Conditional Approval for Subclinical HCM in Cats + RAPACAT Trial Data\nlang: en\nsource: >\n  FOI PDF: pdf-raw/us-approvals/nada-141-604-foi-summary-20260721.pdf (official primary PDF)\n  FDA CVM Update: pdf-raw/us-approvals/fda-cvm-felycin-ca1-2025-03-14.html (official primary HTML)\ndate_parsed: 2026-07-21\ntokens_estimated: 1240\nverification:\n  method: substring_match\n  claims_detail:\n    - {text: \"2025-03-14 FDA Conditional Approval\", passed: true, source: \"FOI PDF §Date of Approval / CVM Update\"}\n    - {text: \"TriviumVet (Waterford, Ireland) sponsor\", passed: true, source: \"FOI PDF §Sponsored by / CVM Update\"}\n    - {text: \"Indication: LV wall thickness ≥6 mm at end diastole\", passed: true, source: \"FOI PDF §Executive Summary verbatim / CVM Update\"}\n    - {text: \"Dosing 0.3 mg/kg orally once weekly\", passed: true, source: \"FOI PDF verbatim / CVM Update verbatim\"}\n    - {text: \"First product approved for use in cats with HCM for any indication\", passed: true, source: \"CVM Update verbatim\"}\n    - {text: \"Conditional Approval basis: subclinical HCM → clinical HCM progression / unmet animal health need\", passed: true, source: \"FOI PDF §Conditional Approval Eligibility / CVM Update\"}\n    - {text: \"sirolimus = rapamycin; produced by Streptomyces hygroscopicus; macrocyclic lactone\", passed: true, source: \"FOI PDF §Executive Summary\"}\n    - {text: \"36 evaluable cats (of 43 enrolled); Felycin-CA1 1X: MWT ↓0.17 mm; Placebo: ↑0.94 mm\", passed: true, source: \"FOI PDF §Study Results verbatim\"}\n    - {text: \"statistical significance at alpha=0.10, Day 60 & Day 180\", passed: true, source: \"FOI PDF §Statistical Methods\"}\n    - {text: \"43 client-owned cats extension study (Dr. Joshua Stern / NC State)\", passed: true, source: \"FOI PDF §TRIV-20 Study\"}\n    - {text: \"Commercial strengths: 0.4 mg / 1.2 mg / 2.4 mg tablets\", passed: true, source: \"CVM Update\"}\n    - {text: \"Conditional Approval valid 1 year, renewable up to 4 times\", passed: true, source: \"FOI PDF §Marketing Status\"}\n    - {text: \"No exclusive marketing rights (§573(c) not applicable)\", passed: true, source: \"FOI PDF §Exclusive Marketing Rights\"}\n    - {text: \"PRN Pharmacal distribution / commercial launch date\", passed: false, reason: \"FOI PDF and CVM Update both contain no PRN Pharmacal wording; source is the manufacturer's press release, not official documents\", removed: true}\n    - {text: \"2025-06 commercial launch timing\", passed: false, reason: \"FOI PDF contains no June 2025 commercial launch content; source is the manufacturer's press release, not official documents\", removed: true}\n    - {text: \"P < 0.05 (precise P value)\", passed: false, reason: \"FOI PDF original uses alpha=0.10 (two-sided); the wording 'P<0.05' does not appear; P<0.05 comes from Tavily notes and is a circular verification\", removed: true}\n    - {text: \"1.11 mm difference (0.94+0.17)\", passed: false, reason: \"FOI PDF does not contain the value 1.11 mm; original only states each group's absolute values separately; 1.11 mm is a manual sum and not a substring of the original\", removed: true}\n    - {text: \"Global expansion (EU EMA / UK VMD / Canada / Australia APVMA)\", passed: false, reason: \"FOI PDF and CVM Update contain no information about global expansion or other countries' regulatory filings; this is an unsourced claim\", removed: true}\n    - {text: \"1 in 7 adult cats prevalence\", passed: false, reason: \"FOI PDF contains no such data; this epidemiological data comes from manufacturer pages or third parties, not official FOI documents\", removed: true}\n    - {text: \"1 in 3 over 9 years prevalence\", passed: false, reason: \"FOI PDF contains no such data; source same as above\", removed: true}\n    - {text: \"Nearly 50% progress to CHF or severe complications\", passed: false, reason: \"FOI PDF contains no such precise percentage; CVM Update only states HCM is progressive / may progress to CHF or sudden death, with no 50% figure\", removed: true}\n  claims_total: 21\n  claims_passed: 13\n  claims_removed: 8\n  date: 2026-07-21\n---\n\n**FDA NADA 141-604 felycin-CA1** (sirolimus delayed-release tablets) is the **first conditionally approved** veterinary drug for **subclinical hypertrophic cardiomyopathy (HCM) in cats** by FDA on 2025-03-14 — the first time FDA has approved any HCM-indication drug (first product approved for use in cats with HCM for any indication). 是 FDA 首次批准任何 HCM 适应症用药。\n\n- **FOI Summary PDF** (official primary / 官方一手): `pdf-raw/us-approvals/nada-141-604-foi-summary-20260721.pdf`\n- **FDA CVM Update announcement** (official primary / 官方一手): `pdf-raw/us-approvals/fda-cvm-felycin-ca1-2025-03-14.html`\n- **Approval date** (批准日期): 2025-03-14\n- **Approval type** (批准类型): **Conditional Approval** (valid 1 year, renewable up to 4 annual renewals / 有条件批准，有效期 1 年，可续 4 次年度)\n- **Sponsor** (发起人): TriviumVet (Waterford, Ireland / 爱尔兰 Waterford)\n- **Research institution** (研究机构): NC State College of Veterinary Medicine (led by Dr. Joshua Stern)\n\n## Product Information (产品信息)\n\n### Basic Properties (基本属性)\n| Field | Value |\n|---|---|\n| Trade name (商品名) | felycin®-CA1 |\n| Generic name (通用名) | sirolimus delayed-release tablets (西罗莫司缓释片) |\n| Species (应用) | Cats (猫) |\n| Dosing (给药) | **0.3 mg/kg orally once weekly** (口服，每周一次) |\n| Dose adjustment (剂量调整) | Must not be split or mixed into food; must be swallowed whole (不可掰碎拌食物，整片吞服) |\n| Strengths (规格) | 0.4 mg / 1.2 mg / 2.4 mg tablets (片剂) |\n| Production organism (生产菌) | Streptomyces hygroscopicus (macrocyclic lactone / 大环内酯) |\n\n### Indication Definition (Subclinical HCM — 适应症定义)\n> \"Subclinical HCM refers to cats with left ventricular (LV) hypertrophy (LV wall thickness of **≥6 mm at end diastole** by 2D or M-mode assessment) in the absence of:\n> - systemic hypertension\n> - other causes of compensatory myocardial hypertrophy\n> - current or historic symptoms of congestive heart failure\n> - arterial thromboembolism\n> - severe LV outflow tract obstruction\"\n\n→ **Echocardiography-confirmed LV wall thickness ≥6 mm** (超声心动图确诊 LV 壁厚 ≥6 mm) + no CHF clinical signs (无 CHF 临床症状)\n\n## Conditional Approval Statutory Basis (Conditional Approval 法定基础)\n\n> \"Animal drug that addresses a serious or life-threatening disease, or addresses an unmet animal or human health need, for which demonstrating effectiveness would require a complex or particularly difficult study or studies is eligible for conditional approval.\"\n\nSubclinical HCM → clinical HCM (CHF / death / aortic thromboembolism) progression → meets \"serious or life-threatening disease\" + \"unmet animal health need\" criteria (符合\"serious or life-threatening disease\" + \"unmet animal health need\").\n\n## RAPACAT Clinical Trial (RAPACAT 临床试验 / Key Data)\n\n### Design (设计)\n- **Type** (类型): well-controlled pilot field study\n- **Sample** (样本): 43 cats enrolled → 36 evaluable at Day 180\n- **Comparator** (对照): Felycin-CA1 (0.3 mg/kg) vs Felycin-CA1 (0.6 mg/kg) vs placebo\n\n### Primary Endpoint (主要终点)\n**Left Ventricular Maximal Wall Thickness (MWT, 左室最大壁厚)**\n\n| Group | Mean change (vs baseline) | n |\n|---|---|---|\n| **Felycin-CA1 0.3 mg/kg (1X)** | **↓0.17 mm** (wall thickness decreased / 壁厚减小) | n=14 |\n| Felycin-CA1 0.6 mg/kg (2X) | ↑0.50 mm | n=10 |\n| Placebo | **↑0.94 mm** (wall thickness increased / 壁厚增加) | n=12 |\n\n### Statistical Analysis (统计分析)\n- Method (方法): RMANCOVA, treatment × time interaction\n- **Significance level (显著性水平): two-sided alpha = 0.10**\n- At both Day 60 and Day 180, the difference between Felycin-CA1 group and the control group reached statistical significance.\n- Placebo group: statistically significant increase in wall thickness vs baseline.\n\n> ⚠️ Note: The FOI PDF original reports **alpha=0.10**, not the \"P<0.05\" found in some note sources. Exact P values are not disclosed in the FOI Summary.\n> 注：FOI PDF 原文报告的是 **alpha=0.10**，而非某些笔记来源中的\"P<0.05\"。精确 P 值未在 FOI Summary 中披露。\n\n## 43 Client-Owned Cats Extension Study (43 client-owned cats 扩展研究 / NC State)\n\n- Sample (样本): 43 client-owned cats with subclinical HCM (n=15 low-dose, n=15 high-dose, n=13 placebo)\n- Low-dose 0.3 mg/kg group (低剂量 0.3 mg/kg 组): MWT decreased at Day 180 vs baseline\n- High-dose 0.6 mg/kg group (高剂量 0.6 mg/kg 组): some cats (3/15) progressed to congestive heart failure during the study\n- Investigator (研究者): Dr. Joshua Stern, NC State College of Veterinary Medicine\n\n## Sirolimus Active Substance (Sirolimus 活性成分)\n\n| Dimension | Content |\n|---|---|\n| Synonym (别名) | rapamycin (雷帕霉素) |\n| Chemical class (化学分类) | macrocyclic lactone (大环内酯) |\n| Production organism (生产菌) | Streptomyces hygroscopicus |\n| First human approval (人类首批准) | 1999 (FDA, organ transplant immunosuppressant, Rapamune) |\n| Veterinary (cat) (兽用（猫）) | 2025-03-14 (Conditional Approval, felycin-CA1) |\n| Mechanism of action (作用机制) | Inhibits mTOR pathway (哺乳动物雷帕霉素靶蛋白) → blocks pathological cardiomyocyte hypertrophy (阻止心肌细胞病理性肥大) |\n| Cat dose expectations (猫剂量预期) | Does not produce immunosuppression (confirmed by rabies vaccine response study / 不产生免疫抑制) |\n\n## Clinical Use Requirements (临床使用要求)\n\n### Required Pre-Prescription Examinations (处方前必备检查)\n- ✅ **Echocardiographic confirmation of HCM** (超声心动图确诊 HCM) (within 9 months)\n- ✅ Blood pressure examination (血压检查)\n- ✅ Liver function tests (肝功能检查): before medication, after 1 month, then every 6-12 months\n\n### Contraindications (禁忌)\n- ❌ Diabetic cats (糖尿病猫)\n- ❌ Severe heart failure (严重心衰)\n- ❌ Cats with liver disease (肝病猫)\n- ❌ Must not be combined with other immunosuppressants (不可与其他免疫抑制剂联用)\n\n## Administrative Information (行政信息)\n\n| Field | Content |\n|---|---|\n| NADA Number (NADA 编号) | 141-604 |\n| Validity Period (有效期) | Conditional Approval 1 year, renewable up to 4 times (annually / 每年) |\n| Marketing status (市场状态) | Rx only — requires licensed veterinarian prescription (须执业兽医处方) |\n| Exclusive marketing rights (独家营销权) | None (§573(c) does not apply — not a designated new animal drug / 非 designated new animal drug) |\n| Patent information (专利信息) | See FDA Green Book |\n\n## Slice Navigation (切片导航)\n\n- FDA Green Book pet Section 55 Entries (US-1) — FDA Green Book pet 段 55 条：see `fda-green-book-recent-approvals/01_pet_drug_approvals_2024_2026.md`\n- FDA Import Alerts (US-2) — FDA Import Alerts：see `fda-import-alerts/01_pet_food_dwpe_alerts_2025_2026.md`\n- FDA OASIS Import Refusals (US-3) — FDA OASIS Import Refusals：see `fda-oasis-import-refusals/01_dashboard_overview_and_animal_feed_category.md`\n\n**Source**: `pdf-raw/us-approvals/nada-141-604-foi-summary-20260721.pdf` (FOI Summary official PDF) + `pdf-raw/us-approvals/fda-cvm-felycin-ca1-2025-03-14.html` (CVM Update official HTML)\n\n**⚠️ Removed Claims (已移除声明 / removed_claims):** This topic originally contained 8 unsourced claims that have been removed per the C1 §3 standard. These include: precise P<0.05 P value, 1.11 mm difference, PRN Pharmacal commercial launch date (June 2025), global expansion EMA/VMD/Canada/Australia filings, 1 in 7 / 1 in 3 prevalence, near-50% progression rate. See frontmatter `verification.claims_detail`. 本 topic 原文包含 8 条无官方来源的声明，已按 C1 §3 规范移除。","sources":[],"tokens_estimated":1740,"generated_at":null,"tip":"Use /api/v1/topics to discover more topics. /api/v1/nutrient for precise single-point queries. /api/v1/cross_compare for 2-3 standard comparisons."}