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Lonvoguran ziclumeran (lonvo-z)

Hereditary angioedema

Also known as NTLA-2002
Last updated
82 sources

Product information and disease descriptionProduct description

Phase of product development

10 evidence topics · 9 sources

Investigational status

“Lonvo-z is an investigational product that has not been approved by FDA or any Health Authority. Its efficacy and safety have not been established.” (opens the source at this quote in a new tab)

Regulatory submission: Rolling BLA initiated April 2026 and accepted September 2026

“initiated a rolling submission of a biologics license application (BLA)” (opens the source at this quote in a new tab)

“In April 2026, we announced the initiation of a rolling biologics license application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for lonvo-z.” (opens the source at this quote in a new tab)

“Sept. 08, 2026 (GLOBE NEWSWIRE)” (opens the source at this quote in a new tab)

“has accepted the Biologics License Application (BLA) for lonvo-z” (opens the source at this quote in a new tab)

FDA acceptance, review designation, target action date, and advisory committee

“accepted the Biologics License Application (BLA)” (opens the source at this quote in a new tab)

“Priority Review” (opens the source at this quote in a new tab)

“PDUFA target action date of March 10, 2027” (opens the source at this quote in a new tab)

“not currently planning to hold an advisory committee” (opens the source at this quote in a new tab)

Launch: Anticipated in the first half of 2027

“If approved, Intellia plans to launch lonvo-z commercially in the first half of 2027.” (opens the source at this quote in a new tab)

FDA orphan drug designation

“has granted orphan drug designation for Intellia’s in vivo CRISPR/Cas9 genome editing candidate, NTLA-2002” (opens the source at this quote in a new tab)

FDA Regenerative Medicine Advanced Therapy designation

“granted Regenerative Medicine Advanced Therapy (RMAT) designation to NTLA-2002 for the treatment of hereditary angioedema (HAE).” (opens the source at this quote in a new tab)

Additional international regulatory designations: European Union

“orphan designation in the European Union” (opens the source at this quote in a new tab)

Additional international regulatory designations: United Kingdom

“Innovation Passport” (opens the source at this quote in a new tab)

Additional international regulatory designations: European Medicines Agency

“Priority Medicine (“PRIME”) program” (opens the source at this quote in a new tab)

Reviews and editorial publications: kallikrein inhibitors in preclinical and early phase studies

“Lastly, NTLA-2002 is an investigational gene-editing therapy.” (opens the source at this quote in a new tab)