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The FDA is expected to decide on Lonvo-z for Hereditary angioedema by March 10, 2027, under a BLA from Intellia Therapeutics.
What the FDA is deciding on Lonvo-z for Hereditary angioedema
The FDA is reviewing Intellia Therapeutics' application to approve Lonvo-z (lonvoguran ziclumeran) for hereditary angioedema.
Would be the first in vivo CRISPR gene editing therapy for hereditary angioedema, given as a single one-time infusion.
Who the Lonvo-z decision matters to
Hereditary Angioedema is a rare genetic disorder characterized by sudden, severe swelling (angioedema) of skin and mucous membranes affecting the face, hands, feet, gastrointestinal tract, and potentially the airway. Most cases result from deficiency of C1-esterase inhibitor, a protein that regulates inflammatory pathways.
Attacks are unpredictable and can be life-threatening if the airway is affected.
Prevalence: Approximately 1 in 10,000 to 50,000 people; estimated 5,000-10,000 people in the United States. See our full Hereditary Angioedema page for current treatments, recruiting trials, and community resources.
What an approval or a rejection of Lonvo-z would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. The letter describes what the FDA wants addressed, and the company then decides whether to resubmit, run more studies or stop. Either way, this page updates with the outcome and what it means.
Where Hereditary Angioedema treatment stands today
Read our full Hereditary Angioedema treatment summary
Research in Hereditary Angioedema is transforming treatment with a diverse array of new approaches targeting different points in the disease pathway. Kallikrein inhibitors, Factor XII inhibitors, and bradykinin receptor antagonists represent multiple strategic approaches to preventing attacks and reducing their frequency and severity.
Three newer medicines were FDA approved in 2025, each for people 12 and older.
Garadacimab (Andembry), a once-monthly injection under the skin that blocks activated factor XII, was approved in June 2025 to prevent attacks. Sebetralstat (Ekterly), a plasma kallikrein inhibitor taken as tablets by mouth at the first sign of an attack, was approved in July 2025 to treat attacks.
Donidalorsen (Dawnzera), an antisense medicine (a drug that lowers the body's production of the protein prekallikrein) injected under the skin every 4 or 8 weeks, was approved in August 2025 to prevent attacks. Long-acting prophylactic therapies offer the promise of sustained protection, while on-demand treatments for acute attacks continue being refined for faster symptom relief.
Trials are investigating how to best use these newer options as first-line prophylaxis and how to optimize long-term prophylaxis strategies that maximize quality of life while minimizing medication burden. Specialty centers focused on immunology and rare diseases often have direct access to trial information and can provide comprehensive care coordination tailored to your specific needs.
The Hereditary Angioedema page has every treatment and trial →Meanwhile, 15 Hereditary Angioedema studies are open or about to open
Whatever the FDA decides here, research on Hereditary Angioedema does not stop. Of these, 6 test a treatment; the others follow patients over time. The most recently updated:
We'll email you when the decision is public, with what it means in plain language, and when new trials open for Hereditary Angioedema. Unsubscribe anytime.
- Trial Alerts, when a new trial opens or a trial changes
- Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
Frequently asked questions
When will the FDA decide on Lonvo-z?
The FDA's target date (PDUFA date) for Lonvo-z in Hereditary angioedema is March 10, 2027.
Who disclosed it: Intellia Therapeutics. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: Intellia press release
What is Lonvo-z being reviewed for?
Intellia Therapeutics submitted a BLA for Lonvo-z in Hereditary angioedema.
What to know: Would be the first in vivo CRISPR gene editing therapy for hereditary angioedema, given as a single one-time infusion.
Is there already an FDA-approved treatment for Hereditary Angioedema?
Yes. Trial Friend's drug list includes 6 FDA-approved drugs for Hereditary Angioedema.
Approved: Firazyr (icatibant), Takhzyro (lanadelumab), Orladeyo (berotralstat), Andembry (garadacimab), Ekterly (sebetralstat), Dawnzera (donidalorsen).
Check: the Hereditary Angioedema page also searches FDA drug labels for approved treatments.
Can I get Lonvo-z before the FDA decides?
Usually only through a clinical trial or an expanded access program, and the company decides whether to offer one.
Trials: 15 Hereditary Angioedema studies are open or about to open, 6 of them testing a treatment. See them.
Check your fit: Match Me compares your details with every open trial.
Expanded access: your doctor can ask Intellia Therapeutics directly. Registered programs are listed on ClinicalTrials.gov.
How much will Lonvo-z cost?
Intellia Therapeutics has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Lonvo-z decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Intellia press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.