Animal NDC 25682-020-01 Hlal Rdna Construct In Sbc Lal-c Chickens
Hlal Rdna Construct In Sbc Lal-c Chicken

Animal Product Information

Field Name Field Value
Animal NDC Code 25682-020-01
Proprietary Name Hlal Rdna Construct In Sbc Lal-c Chickens What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Hlal Rdna Construct In Sbc Lal-c Chicken What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Alexion Pharmaceuticals, Inc.
Product Type Recombinant Deoxyribonucleic Acid Construct
Active Ingredient(s)
  • Hlal Rdna Construct In Sbc Lal-c Chicken
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA141453 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Hlal Rdna Construct In Sbc Lal-c Chickens Images

Hlal Rdna Construct In Sbc Lal-c Chickens Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Heritable construct

Manufactured by:

Alexion Pharmaceuticals, Inc.

121 Seaport Boulevard,

Boston, MA 02210.

Approved by FDA under NADA #141-453

[version 002/2020]

November/2020
Alexion Pharmaceuticals, Inc.


1. Product Identification



hLAL rDNA construct integrated at a single site (the SYN LAL-C site in chromosome 6) as a single copy, in a specific, diploid line (SBC LAL-C

SBC LAL-C is the name Alexion designated for their lineage of chickens, and is not representative of the regulated article, which is subject to FDA approval. The FDA-regulated article subject to this approval is the intentional genomic alteration (hLAL rDNA construct) in the chickens.

) of hemizygous and homozygous domestic chickens (Gallus gallus) derived from the lineage progenitor XLL 109, expressing a recombinant human lysosomal acid lipase (rhLAL) encoding gene such that rhLAL protein (intended for the treatment of humans) is present in their egg whites.


2. Warnings And Precautions



SBC LAL-C chickens, or any materials derived from them, are not intended to enter the human or animal food supply.


3. Animal Safety



Data from the following comparisons of SBC LAL-C chickens to comparator chickens (without an intentional genomic alteration; IGA) demonstrated a lack of adverse effect due to the rDNA construct, or to the recombinant human LAL protein, on the SBC LAL-C chicken.

Mortality rates

Mortality as attributed to animal death and euthanasia for items such as broken legs/wings, cloacal prolapse or other injury.

for SBC LAL-C chickens and comparators without an IGA housed under similar conditions are presented in Table 1. These data include mortality rates collected at multiple Alexion animal facilities housing multiple generations of SBC LAL-C chickens collected during 2015 to 2017.

Table 1: Historical Mortality Results for SBC LAL-C Hens (Measured by Age)
Hen Age (weeks)21-2526-3031-3536-4041-4546-5051-5556-6061-6566-7071-7576-80
Average Weekly Mortality Rate

Based on data from 19 populations, years 2015 through 2017

0.05%0.10%0.22%0.17%0.21%0.19%0.26%0.39%0.38%0.37%0.38%0.74%
Standard Deviation0.12%0.19%0.30%0.28%0.32%0.32%0.32%0.42%0.46%0.44%0.47%1.34%
Comparator Hens

Comparator chickens (hens) are those without an intentional genomic alteration

0%0.13%0.20%0.48%0.07%0.07%0.58%0.23%0.17%N/AN/AN/A

In a study to compare physiological endpoints SBC LAL-C vs. comparator chickens without an IGA, blood samples were collected for serological assays, and chickens were presented for post-mortem examination for gross/histological evaluations. No differences between LAL-C chickens and comparators without an IGA were evident based on the following evaluations: serology and histopathology, including CBC (complete blood count), comprehensive blood chemistry, triglycerides and LDH (lactate dehydrogenase) and histopathological examination of multiple tissues.

SBC LAL-C hens produced eggs over a 3-year period at the same average annual rate as comparator hens without an IGA housed under similar conditions (Table 2).

These values are also consistent with the 280 eggs per hen produced per year reported for White Leghorn flocks in commercial egg production facilities

Austic, R. E., Nesheim, M. C. Poultry production, 1990, Lea & Febiger, Philadelphia, US

.

Table 2:Egg Production Rates for LAL-C Chickens and Comparators without an Intentional Genomic Alteration
Hen Age (weeks)25303540455055606570
SBC LAL-C Hens:
Average

Based on data from eight production rooms at two production facilities

28.958.487.4116.2145.9174.4201.6224.2247.5272.1
Standard Deviation4.34.35.36.37.78.79.811.313.714.7
Comparator Hens

Comparator chickens (hens) are those without an intentional genomic alteration

Average316393118147173198222248274

The data for SBC LAL-C chickens versus comparator chickens without an IGA demonstrates no significant differences in, mortality, general health status or egg production.


4. Effectiveness



Multiple generations of the SBC LAL-C line have demonstrated genetic consistency as established through genetic tests for the presence of the hLAL rDNA construct, hLAL rDNA DNA sequence fidelity and hLAL rDNA construct integration site consistency. For each generation, phenotypic consistency has been established based on the presence of recombinant human LAL enzyme activity in egg white.


5. Limitations Of Use



The SBC LAL-C lineage must be housed in only those Alexion Pharmaceutical, Inc. facilities specified in the approved application.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.