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VeterinaryAntibody Medicines and Gene-Edited Animals
Twenty flashcards on veterinary biotechnology the FDA has already approved or reviewed: antibody drugs for pets and gene-edited animals.
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20 cards
- First monoclonal antibody the FDA approved for any animal?
- Solensia (frunevetmab), for osteoarthritis pain in cats, approved January 13, 2022.
- What makes frunevetmab 'felinized'?
- It is a mouse antibody with every part swapped for the cat version except the regions that bind the target.
- What does frunevetmab block?
- Nerve growth factor (NGF), a protein involved in pain.
- How is Solensia given?
- Under the skin once a month, at least 1 mg/kg; each vial holds 7 mg.
- How did the FDA decide Solensia works?
- By weight of evidence: owner and veterinarian scores in two studies both favored it.
- First monoclonal antibody approved for dogs?
- Librela (bedinvetmab), approved May 5, 2023, for osteoarthritis pain.
- How common is osteoarthritis in dogs?
- At least 25 % of dogs get it at some point in life.
- How does bedinvetmab work?
- It binds canine NGF so the pain signal does not reach the brain.
- How was Librela tested?
- Two field studies (US and EU) in owned dogs; owners scored pain with the Canine Brief Pain Inventory.
- How is Librela given?
- Under the skin monthly, at least 0.5 mg/kg, by prescription from a veterinarian.
- Who makes Librela?
- Zoetis, based in Kalamazoo, Michigan.
- What is an intentional genomic alteration (IGA)?
- A change made to an animal's DNA with modern tools such as genetic engineering or genome editing.
- How many IGA applications has the FDA approved, and the first?
- Five; the first, in 2009, a goat that makes a human medicine in its milk.
- Gene-altered fish approved for food in 2015?
- AquAdvantage Salmon, an Atlantic salmon approved November 19, 2015.
- GalSafe pigs: what was new?
- Approved December 2020, the first IGA approved for both human food and possible medical uses.
- What does the GalSafe alteration do?
- It disrupts the GGTA1 gene, so the pigs have no detectable alpha-gal sugar.
- Who can benefit from GalSafe meat?
- People with alpha-gal syndrome, a red meat allergy linked to Lone Star tick bites.
- Why does no alpha-gal matter for transplants?
- Alpha-gal triggers fast rejection, so pig tissues without it may cause fewer immune reactions.
- PRLR-SLICK cattle?
- A CRISPR edit in the PRLR gene gives a short slick coat linked to heat tolerance; FDA risk review in 2022, updated September 2025.
- Other gene-edited cattle on the FDA's risk-reviewed list?
- Acceligen's polled (hornless) Black Wagyu and Line 1 Hereford, with the Celtic polled alteration.
Official sources
U.S. Food and Drug Administration, Center for Veterinary Medicine
Freedom of Information Summary, NADA 141-546, Solensia (frunevetmab injection), approved January 13, 2022
U.S. Food and Drug Administration, Center for Veterinary Medicine
Innovation in Animal Drug Development
U.S. Food and Drug Administration, Center for Veterinary Medicine
FDA Approves First Monoclonal Antibody for Dogs with Osteoarthritis Pain (May 5, 2023)
U.S. Food and Drug Administration, Center for Veterinary Medicine
Q&A for Consumers on Intentional Genomic Alterations in Animals
U.S. Food and Drug Administration, Center for Veterinary Medicine
Freedom of Information Summary, NADA 141-542, GalSafe pigs (pPL657 rDNA construct), approved December 14, 2020
U.S. Food and Drug Administration, Center for Veterinary Medicine
Risk Assessment Summary, PRLR-SLICK cattle (date of decision September 25, 2025)
U.S. Food and Drug Administration, Center for Veterinary Medicine
Intentional Genomic Alterations (IGAs) in Animals: Risk-Reviewed IGAs
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