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。
- FOI Summary PDF (official primary / 官方一手):
pdf-raw/us-approvals/nada-141-604-foi-summary-20260721.pdf - FDA CVM Update announcement (official primary / 官方一手):
pdf-raw/us-approvals/fda-cvm-felycin-ca1-2025-03-14.html - Approval date (批准日期): 2025-03-14
- 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)
- Sponsor (发起人): TriviumVet (Waterford, Ireland / 爱尔兰 Waterford)
- Research institution (研究机构): NC State College of Veterinary Medicine (led by Dr. Joshua Stern)
Product Information (产品信息)
Basic Properties (基本属性)
| Field | Value |
|---|---|
| Trade name (商品名) | felycin®-CA1 |
| Generic name (通用名) | sirolimus delayed-release tablets (西罗莫司缓释片) |
| Species (应用) | Cats (猫) |
| Dosing (给药) | 0.3 mg/kg orally once weekly (口服，每周一次) |
| 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) |
| Strengths (规格) | 0.4 mg / 1.2 mg / 2.4 mg tablets (片剂) |
| Production organism (生产菌) | Streptomyces hygroscopicus (macrocyclic lactone / 大环内酯) |
Indication Definition (Subclinical HCM — 适应症定义)
> "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: > - systemic hypertension > - other causes of compensatory myocardial hypertrophy > - current or historic symptoms of congestive heart failure > - arterial thromboembolism > - severe LV outflow tract obstruction"
→ 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)
Conditional Approval Statutory Basis (Conditional Approval 法定基础)
> "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."
Subclinical 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").
RAPACAT Clinical Trial (RAPACAT 临床试验 / Key Data)
Design (设计)
- Type (类型): well-controlled pilot field study
- Sample (样本): 43 cats enrolled → 36 evaluable at Day 180
- Comparator (对照): Felycin-CA1 (0.3 mg/kg) vs Felycin-CA1 (0.6 mg/kg) vs placebo
Primary Endpoint (主要终点)
Left Ventricular Maximal Wall Thickness (MWT, 左室最大壁厚)
| Group | Mean change (vs baseline) | n |
|---|---|---|
| Felycin-CA1 0.3 mg/kg (1X) | ↓0.17 mm (wall thickness decreased / 壁厚减小) | n=14 |
| Felycin-CA1 0.6 mg/kg (2X) | ↑0.50 mm | n=10 |
| Placebo | ↑0.94 mm (wall thickness increased / 壁厚增加) | n=12 |
Statistical Analysis (统计分析)
- Method (方法): RMANCOVA, treatment × time interaction
- Significance level (显著性水平): two-sided alpha = 0.10
- At both Day 60 and Day 180, the difference between Felycin-CA1 group and the control group reached statistical significance.
- Placebo group: statistically significant increase in wall thickness vs baseline.
> ⚠️ 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. > 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。
43 Client-Owned Cats Extension Study (43 client-owned cats 扩展研究 / NC State)
- Sample (样本): 43 client-owned cats with subclinical HCM (n=15 low-dose, n=15 high-dose, n=13 placebo)
- Low-dose 0.3 mg/kg group (低剂量 0.3 mg/kg 组): MWT decreased at Day 180 vs baseline
- 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
- Investigator (研究者): Dr. Joshua Stern, NC State College of Veterinary Medicine
Sirolimus Active Substance (Sirolimus 活性成分)
| Dimension | Content |
|---|---|
| Synonym (别名) | rapamycin (雷帕霉素) |
| Chemical class (化学分类) | macrocyclic lactone (大环内酯) |
| Production organism (生产菌) | Streptomyces hygroscopicus |
| First human approval (人类首批准) | 1999 (FDA, organ transplant immunosuppressant, Rapamune) |
| Veterinary (cat) (兽用（猫）) | 2025-03-14 (Conditional Approval, felycin-CA1) |
| 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) |
| 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) |
Clinical Use Requirements (临床使用要求)
Required Pre-Prescription Examinations (处方前必备检查)
- ✅ Echocardiographic confirmation of HCM (超声心动图确诊 HCM) (within 9 months)
- ✅ Blood pressure examination (血压检查)
- ✅ Liver function tests (肝功能检查): before medication, after 1 month, then every 6-12 months
Contraindications (禁忌)
- ❌ Diabetic cats (糖尿病猫)
- ❌ Severe heart failure (严重心衰)
- ❌ Cats with liver disease (肝病猫)
- ❌ Must not be combined with other immunosuppressants (不可与其他免疫抑制剂联用)
Administrative Information (行政信息)
| Field | Content |
|---|---|
| NADA Number (NADA 编号) | 141-604 |
| Validity Period (有效期) | Conditional Approval 1 year, renewable up to 4 times (annually / 每年) |
| Marketing status (市场状态) | Rx only — requires licensed veterinarian prescription (须执业兽医处方) |
| 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) |
| Patent information (专利信息) | See FDA Green Book |
Slice Navigation (切片导航)
- 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 - FDA Import Alerts (US-2) — FDA Import Alerts：see
fda-import-alerts/01_pet_food_dwpe_alerts_2025_2026.md - FDA OASIS Import Refusals (US-3) — FDA OASIS Import Refusals：see
fda-oasis-import-refusals/01_dashboard_overview_and_animal_feed_category.md
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)
⚠️ 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。