Last reviewed · How we verify
Takhzyro (LANADELUMAB)
Lanadelumab-flyo binds and inhibits plasma kallikrein, reducing bradykinin generation and controlling angioedema in HAE.
At a glance
| Generic name | LANADELUMAB |
|---|---|
| Sponsor | Dyax Corp |
| Drug class | Plasma Kallikrein Inhibitor [EPC] |
| Target | plasma kallikrein |
| Modality | Monoclonal antibody |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2018 |
| Annual revenue | 1500 |
Mechanism of action
Lanadelumab-flyo is a monoclonal antibody that targets plasma kallikrein, a protein involved in generating bradykinin, a potent vasodilator. By inhibiting plasma kallikrein, the drug reduces the production of bradykinin, thereby preventing the swelling and pain associated with hereditary angioedema (HAE).
Approved indications
- Hereditary angioneurotic edema
Common side effects
- Injection site reactions
- Upper respiratory infection
- Headache
- Rash
- Diarrhea
- Dizziness
- Myalgia
- Hypersensitivity
- Increased aspartate transaminase
- Increased alanine transaminase
Key clinical trials
- A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE) in the Kingdom of Saudi Arabia
- A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
- A Study of Lanadelumab in Children With Hereditary Angioedema (HAE) in Multiple Countries
- A Survey of Lanadelumab in Participants With Hereditary Angioedema
- A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China
- Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease (PHASE2)
- A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)
- A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |