DELETION OF EXON 7 OF CD163 GENE IN DOMESTIC PIGS not applicable
Drug Labeling and Warnings
Drug Details [pdf]
-
1. DESCRIPTION
1.1 Product Identification
Deletion of exon 7 of CD163 gene (abbreviated CD163ΔE7) in domestic pigs (Sus scrofa domesticus). Breeding lines containing one copy (heterozygous) or two copies (homozygous) of CD163ΔE7 may be identified with the registered tradename “EverThrive™ PRP”. However, only pigs carrying two copies of CD163ΔE7 (homozygous) are intended to be resistant to Porcine Reproductive and Respiratory Syndrome Virus (PRRSV).
1.2 Product Claim
Deletion of exon 7 of the CD163 gene in domestic pigs (Sus scrofa domesticus) is intended to confer resistance to porcine reproductive and respiratory syndrome virus (PRRSV) in homozygous pigs. Pigs carrying one or two copies of CD163ΔE7, and their offspring, are intended for breeding or to be used as sources of food.
1.3 Uses
Product Label 1: Homozygous Pigs.
Pigs bearing this label are CD163ΔE7 homozygous and are resistant to PRRSV.
Resistance to PRRSV in the progeny of this pig (and from semen derived from this pig) is affected by the genetic background of the other parent pig it is bred to:
If the other parent is CD163ΔE7 homozygous (two copies), all progeny will be resistant to PRRSV.
If the other parent is CD163ΔE7 heterozygous (one copy), approximately one half of the progeny will be resistant to PRRSV.
If the other parent has no CD163ΔE7, none of the progeny will be resistant to PRRSV.Product Label 2: Semen from Homozygous Pigs.
Semen bearing this label will produce offspring that may or may not be resistant to PRRSV.
Resistance to PRRSV in the progeny of this semen is affected by the genetic background of the other parent pig it is bred to:
If the other parent is CD163ΔE7 homozygous (two copies), all progeny will be resistant to PRRSV.
If the other parent is CD163ΔE7 heterozygous (one copy), approximately one half of the progeny will be resistant to PRRSV.
If the other parent has no CD163ΔE7, none of the progeny will be resistant to PRRSV.Product Label 3: Heterozygous Pigs.
Pigs bearing this label are CD163ΔE7 heterozygous and are not resistant to PRRSV.
Resistance to PRRSV in the progeny of this pig (and from semen derived from this pig) is affected by the genetic background of the other parent pig it is bred to:
If the other parent is CD163ΔE7 homozygous (two copies), approximately one half of the progeny will be resistant to PRRSV.
If the other parent is CD163ΔE7 heterozygous (one copy), approximately one in four of the progeny will be resistant to PRRSV.
If the other parent has no CD163ΔE7, none of the progeny will be resistant to PRRSV.Product Label 4: Semen from Heterozygous Pigs.
Semen bearing this label will produce offspring that may or may not be resistant to PRRSV.
Resistance to PRRSV in the progeny of this semen is affected by the genetic background of the other parent pig it is bred to:
If the other parent is CD163ΔE7 homozygous (two copies), approximately one half of the progeny will be resistant to PRRSV.
If the other parent is CD163ΔE7 heterozygous (one copy), approximately one in four of the progeny will be resistant to PRRSV.
If the other parent has no CD163ΔE7, none of the progeny will be resistant to PRRSV.Product Label 5: Ungenotyped Pigs.
Pigs bearing this label may contain one, two or no copies of CD163ΔE7 and are of unknown resistance to PRRSV.
-
2. WARNINGS AND PRECAUTIONS
Product Labels 1 and 3.
Deletion of exon 7 of the CD163 gene is a recessive genetic trait and only confers resistance to PRRSV in homozygous pigs (two copies). Pigs bearing this label will produce offspring that may or may not be resistant to PRRSV. See 1.3 Uses for additional information.
Product Labels 2 and 4.
Deletion of exon 7 of the CD163 gene is a recessive genetic trait and only confers resistance to PRRSV in homozygous pigs (two copies). Semen bearing this label will produce offspring that may or may not be resistant to PRRSV. See 1.3 Uses for additional information.
Product Label 5.
Deletion of exon 7 of the CD163 gene is a recessive genetic trait and only confers resistance to PRRSV in homozygous pigs (two copies). Pigs bearing this label may contain one, two or no copies of the CD163ΔE7 gene and are of unknown resistance to PRRSV. Pigs bearing this label will produce offspring that may or may not be resistant to PRRSV. See 1.3 Uses for additional information.
-
3. EFFECTIVENESS
In six live animal viral challenge studies, CD163ΔE7 homozygous pigs of multiple consecutive generations demonstrated resistance to infection following inoculation with one of seven PRRSV Type II isolates and two PRRSV Type I isolates. In these controlled studies consisting of 101 CD163ΔE7 homozygous pigs and 108 age-matched controls (CD163ΔE7 heterozygous pigs and pigs without a CD163 alteration), resistance to PRRSV infection was determined by demonstrating undetectable PRRSV RNA in serum samples (via PCR) and undetectable PRRSV antibody seroconversion (by ELISA) 21 days following viral inoculation. All CD163ΔE7 homozygous pigs were resistant to infection following inoculation with one of seven PRRSV Type II isolates and two PRRSV Type I isolates listed in Table 1, whereas no control pigs demonstrated resistance.
Table 1. Live Animal Viral Challenge Study Results Organized by PRRSV Inoculant
PRRSV Type and Lineage (if applicable)
PRRSV
Inoculant and RFLP*
(if applicable)
Number of CD163ΔE7
Homozygous IGA
Animals
Success Rate (%)**
in CD163ΔE7
Homozygous Animals
Number of Control Animals
Success Rate (%)**
in Control Animals
Type II, L8
NVSL97-7895
23
100
26
0
Type II, L1C
UIL21-0712 (RFLP 1-4-4)
21
100
16
0
Type II, L1H
USA/NE/2634- 1/2022 (RFLP
1-8-4)
5
100
5
0
Type II, L1A
USA/IN/65239- GA/2014 (RFLP 1-7-4)
5
100
5
0
Type II, L1E
USA/OK/2791- 12/2022 (RFLP
1-4-2)
5
100
5
0
Type II,
L1D
MLV vaccine
(RFLP 1-8-4)
5
100
5
0
Type II, L5
USA/IL/23295- GA-2022 (RFLP 2-5-2)
5
100
5
0
Type I
SD13-15
22
100
27
0
Type I
SD01-08
10
100
14
0
* RFLP = Restriction Fragment Length Polymorphism, a commonly used way of classifying PRRSV strains.
** Success rate is the proportion of animals with undetectable PRRSV RNA in serum samples and undetectable PRRSV antibody seroconversion on study day 21.
In two studies, two out of twenty-six CD163ΔE7 homozygous pigs demonstrated resistance following inoculation with a PRRSV Type II – KS06 inoculant (Table 2). The clinical relevance of the reported lack of resistance of CD163ΔE7 homozygous pigs to the KS06 isolate is undetermined; this isolate and the lineage to which it is classified were not reported in the commercial swine population of the United States at an appreciable level at the time of evaluation (2022-2023).
Table 2. Live Animal Viral Challenge Study Results Following PRRSV Type II – KS06 Inoculation
PRRSV
Type and Lineage
PRRSV
Inoculant
Number of CD163ΔE7
Homozygous IGA Animals
Success Rate (%)* in CD163ΔE7
Homozygous Animals
Number of Control Animals
Success Rate (%)* in Control Animals
Type II, L6
KS06-72109
26
8
22
0
* Success rate is the proportion of animals with undetectable PRRSV RNA in serum samples and undetectable PRRSV antibody seroconversion on study day 21.
-
4. TARGET ANIMAL SAFETY
In controlled farm studies, pigs containing two copies (homozygous) or one copy (heterozygous) of CD163ΔE7 showed no significant differences from unedited (null) pigs for most phenotypic characteristics observed across the lifecycle of the pigs. Differences observed between groups in the studies were not clinically significant and were consistent with reported ranges for commercial pigs.
Tables 3-4 summarize the results of the observational studies on pigs of Genus PIC elite breeding line L03. Similar data were collected for three additional breeding lines (L02, L65, and L800), demonstrating consistent safety outcomes across all lines studied.
Table 3. Phenotypic Characterization Across Life Stages
Least squares mean (LS Mean) and tests of significance among homozygous (CD163ΔE7/ΔE7), heterozygous edited (CD163ΔE7/+), and unedited (null, CD163+ /+) pigs for phenotypic characteristics across the lifecycle of the pigs. N (number of animals observed); BWT (individual piglet birth weight, kg); TEAT (total teat count); WT140 (individual bodweight of pig at 140 days of age, kg); LDG (lifetime daily gain, g per day); BF (ultrasound predicted 10th rib backfat depth, mm); LD (ultrasound predicted 10th rib loin depth, mm); *p < 0.05. **p < 0.01.
CD163ΔE7/ΔE7
CD163ΔE7/+
CD163+/+
Trait
N
LS
Mean
N
LS
Mean
N
LS
Mean
Early Life Traits
BWT
121
1.30
298
1.23
138
1.26
TEAT
121
15.91
298
16.16
138
15.97
FinishingTraits
WT140
55
93.17
58
88.41
55
88.77
LDG
55
636.96
58
614.38
55
611.83
BF
55
8.98
58
10.17**
55
9.99*
LD
55
63.54
58
64.60
55
65.09
Table 4. Female Reproductive Traits
Least squares mean (LS Mean) and tests of significance among homozygous (CD163ΔE7/ΔE7), heterozygous edited (CD163ΔE7/+), and unedited (null, CD163+/+) pigs for female reproductive traits. N (number of litters); GL (gestation length, days); TNB (total number of piglets born); NBA (number of piglets born alive per litter); NBD (number of piglets born dead per litter); MUM (number of mummified piglets per litter). No differences were significant at the p < 0.05 level.
CD163ΔE7/ΔE7
CD163ΔE7/+
CD163+/+
Trait
N
LS
Mean
N
LS
Mean
N
LS
Mean
GL
6
116.2
6
116.5
6
116.8
TNB
6
12.7
6
12.7
6
13.3
NBA
6
11.8
6
11.7
6
13.0
NBD
6
0.8
6
1.0
6
0.3
MUM
6
0.2
6
0.0
6
0.0
In these studies, morbidity and mortality rates were calculated for each group at various life stages (pre-weaning, nursery, finishing, and reproductive). No clinically significant differences were observed between groups. Morbidity and mortality rates for all groups were consistent with reported ranges for commercial pigs.
Separately, larger populations of pigs were evaluated for morbidity and mortality. Table 5 shows summaries of morbidity and mortality data collected from a larger population of pigs that were homozygous CD163ΔE7 pigs.
Table 5. Mortality and morbidity rates of homozygous CD163ΔE7 pigs under normal Genus PIC production practices.
Percentage (Mean ± SD)
Mortality*
Adult breeding herd
0.2% ± 0.2%
Piglets, pre-weaning
5.0% ± 1.3%
Piglets, post-weaning
0.7% ± 0.6%
Morbidity**
Adult breeding herd
0.8% ± 0.3%
Piglets, post-weaning
12.5% ± 10.8%
Piglets, post-weaning
0.1% ± 0.1%
* Mortality was calculated as the number of mortality events (animals dead or culled for health reasons) in the given sub- population in one week relative to the total number of pigs from the sub-population in the same week, taken from farm-level data across two farms (July to December 2024).
** Morbidity was calculated as the number of morbidity events (animals treated for a morbidity) in the given sub-population in one week relative to the total number of pigs from the sub-population in the same week, taken from farm-level data across two farms (October to December 2024).
- 5. CONTACT INFORMATION
- 6. NAME AND PLACE OF BUSINESS
- 7. PACKAGE LABEL PRINCIPAL DISPLAY PANELS
-
INGREDIENTS AND APPEARANCE
DELETION OF EXON 7 OF CD163 GENE IN DOMESTIC PIGS
deletion of exon 7 of cd163 gene in domestic pigs not applicableProduct Information Product Type Item Code (Source) NDC: 86205-001 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Deletion of exon 7 of CD163 gene in domestic pigs (UNII: G2FPY6HLB3) (Deletion of exon 7 of CD163 gene in domestic pigs - UNII:G2FPY6HLB3) Deletion of exon 7 of CD163 gene in domestic pigs 1 [arb'U] in 1 [arb'U] Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 86205-001-01 1 [arb'U] in 1 NOT APPLICABLE 2 NDC: 86205-001-02 1 [arb'U] in 1 NOT APPLICABLE 3 NDC: 86205-001-03 1 [arb'U] in 1 NOT APPLICABLE 4 NDC: 86205-001-04 1 [arb'U] in 1 NOT APPLICABLE 5 NDC: 86205-001-05 1 [arb'U] in 1 NOT APPLICABLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141609 04/13/2026 Labeler - Genus plc (835053570) Registrant - Genus plc (835053570) Establishment Name Address ID/FEI Business Operations ABS Global Inc 035332321 analysis Establishment Name Address ID/FEI Business Operations PIC USA Inc 119785715 api manufacture Establishment Name Address ID/FEI Business Operations PIC USA Inc 119190951 api manufacture
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.