the allergen extract database assessments l.
Download
Skip this Video
Download Presentation
The allergen extract database: assessments

Loading in 2 Seconds...

play fullscreen
1 / 31

The allergen extract database: assessments - PowerPoint PPT Presentation


  • 183 Views
  • Uploaded on

The allergen extract database: assessments. Ronald L. Rabin, MD Chief, Laboratory of Immunobiochemistry Division of Bacterial, Parasitic and Allergenic Products Office of Vaccines Research and Review Center for Biologics Evaluation and Research, USFDA. Background

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'The allergen extract database: assessments' - arkadiy


Download Now An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
the allergen extract database assessments

The allergen extract database: assessments

Ronald L. Rabin, MD

Chief, Laboratory of Immunobiochemistry

Division of Bacterial, Parasitic and Allergenic Products

Office of Vaccines Research and Review

Center for Biologics Evaluation and Research, USFDA

today s presentations
Background

Allergenics efficacy reviews

Panel 1, 21 CFR 601.25 (1974-1979)

Panel 2, 21 CFR 601.26 (1982-1983)

Current evaluation process (2003-2011)

Safety of allergenic extracts

Assessments

Next steps

Today’s presentations
safety and efficacy of non standarized allergen extracts
Panel 1 reviewed 773 extracts

Category I: 335

Category II: 1

Category IIIA: 431

Category IIIB: 6

Panel 2 reviewed 752 extracts

Category I: 723

Category II: 29

Current review: 1269 extracts

Safety review and literature demonstrates that safety concerns are associated with the procedure of immunotherapy rather than any one product or set of products

Safety and efficacy of non-standarized allergen extracts
format of database
Product

Manufacturers of this Product

Search Strategy

Nomenclature

Parent Product

Related Product

Published Data

Reference Document List

Original and Reclassification Panel recommendations

http://www.fda.gov/BiologicsBloodVaccines/Allergenics/ucm272115.htm

Format of database
format of database product
Format of database: Product

Product Name as listed in FDA files

Product Category

Database entry number

format of database manufacturers of this product
Manufacturers of this Product

Antigen Laboratories, Inc. - Liberty, MO (Lic. No. 468, STN No. 102223)

Greer Laboratories, Inc. - Lenoir, NC (Lic. No. 308, STN No. 101833)

Hollister-Stier Labs, LLC - Spokane, WA (Lic. No. 1272, STN No. 103888)

ALK-Abello Inc. - Port Washington, NY (Lic. No. 1256, STN No. 103753)

Allermed Laboratories, Inc. - San Diego, CA (Lic. No. 467, STN No. 102211)

Nelco Laboratories, Inc. - Deer Park, NY (Lic. No. 459, STN No. 102192)

Allergy Laboratories, Inc. - Oklahoma City, OK (Lic. No. 103, STN No. 101376)

All manufacturers distribute the extract of this species under the same name; not always the case.

Format of database: Manufacturers of this Product
format of database search strategy
Search Strategy

PubMed: "alternaria alternata"; "alternaria tenuis"; "alternaria alternata" allergen; "alternaria tenuis" allergen; "alternaria alternata" immunotherapy

Google: alternaria tenuis allergy; alternaria tenuis allergy adverse; alternaria tenuis allergen; alternaria tenuis allergen adverse

Note that searches included scientific/medical and lay sources

Format of database: Search Strategy
database field nomenclature
Nomenclature

ATCC website: Alternaria alternata (Fries) Keissler, anamorph deposited as Alternaria tenuis Nees, anamorph. Stedmans Book (ATCC Fungus Names, 1993): Alternaria alternata (Fries) Keissler (1912);Synonomy: Alternaria tenuis, Nees 1816; Alternaria tomato (Cooke) Brinkman 1931; Alternaria dioscoreae, Vasant Rao, 1961; Torula alternata Fries 1832. Index Fungorum website: Alternaria alternata (Fr.) Keissl., Beih. bot. Zbl., Abt. 2 29: 434 (1912); Synonymy:Torula alternata Fr., Syst. mycol. (Lundae) 3(2): 500 (1832); Ulocladium consortiale sensu Brook; fide NZfungi (2008); Alternaria tenuis Nees, Syst. Pilze (Würzburg): 72 (1816); Macrosporium asciculatum Cooke & Ellis, Grevillea 6(no. 37): 6 (1877); Alternaria fasciculata (Cooke & Ellis) L.R. Jones & Grout, Bull. Torrey bot. Club 24(5): 257 (1897); Alternaria rugosa McAlpine, Agric. Gaz. N.S.W., Sydney 7:304(1896).

Sources:

ITIS: Integrated Taxonomic Information System; http://www.itis.gov

ATCC: American Type Culture Collection;

http://www.atcc.org/ATCCAdvancedCatalogSearch/tabid/112/Default.aspx

Database field: Nomenclature
format of database recommended names
Recommended Scientific Name Alternaria alternata

Recommendations based on Nomenclature review

Harmonizes nomenclature among products derived from the same species

Minimizes prescription errors

Format of database: Recommended Names
database field parent product
Parent Product

371 - Molds, Rusts and Smuts, Alternaria tenuis (alternata)

Aligns all products (“Parent” with “Related”) derived from the same species into a subset of identical extracts

For alternaria alternata, there are no “related products.”

Database field: Parent Product
database field related product mugwort
Parent Product

1208 - Pollens - Weeds and Garden Plants, Sage, Mugwort, Western Artemisia ludoviciana

Related Products

1146 - Pollens - Weeds and Garden Plants, Mugwort, Darkleaved Artemisia ludoviciana

1147 - Pollens - Weeds and Garden Plants, Mugwort, Western Artemisia ludoviciana

1204 - Pollens - Weeds and Garden Plants, Sage, Mixed Artemisia ludoviciana

1212 - Pollens - Weeds and Garden Plants, Sage, Prairie, Artemisia gnaphaloides

1213 - Pollens - Weeds and Garden Plants, Sage, Western Artemisia gnapholodes

1224 - Pollens - Weeds and Garden Plants, Sagebrush, Prairie Artemisia gnaphalodes

1225 - Pollens - Weeds and Garden Plants, Sagebrush, Prairie Artemisia ludoviciana

1229 - Pollens - Weeds and Garden Plants, Sagebrush, Western Artemisia graphaloides

1230 - Pollens - Weeds and Garden Plants, Sagebrush, White (Prairie) Artemisia ludoviciana

This is an example of products that are “Related” to a “Parent” product

Database field: Related Product (Mugwort)
database field published data
Published Data

A. alternata (and Cladosporium) sensitivity correlates with asthma severity in Europe.

A. alternata was used for diagnosis in several papers, PMID 8842553, 1987459, 10843433, 10200024, 15940136, 15614195, 3993865.

Several trials demonstrate that immunotherapy works in rhinitis, PMID 10843433, 12906784, 15745389, 15736717, 3993865, 2406323, 3381709.

Note severe reactions reported in PMID 3544937.

Publications usually listed by PubMed ID (PMID) for ease of search and download

Brief summary of the report(s)

Database field:Published Data

17

format of database documents
Format of database: Documents

Document: Abbreviated citation

PubMed identification number (PMID)

First Author

Year of publication

internal review determinations 1269 products reviewed
Table 1. Use in Diagnosis and Treatment Addressed in Literature (480)

Table 2. Foods: Use in Diagnosis Addressed in Literature (134)

Table 3. Non-food: Use in Diagnosis Addressed in Literature (73)

Table 4. Minimal or No Literature Relating to Use in Diagnosis and Treatment (566)

Table 5. Potential Safety Issues (16)

Internal review determinations(1269 products reviewed)
table 1 use in diagnosis and treatment addressed in literature
Product: 762 - Pollens - Trees, Box Elder Acer negundo

Manufacturers of this Product

Antigen Laboratories, Inc. - Liberty, MO (Lic. No. 468, STN No. 102223)

Greer Laboratories, Inc. - Lenoir, NC (Lic. No. 308, STN No. 101833)

Hollister-Stier Labs, LLC - Spokane, WA (Lic. No. 1272, STN No. 103888)

ALK-Abello Inc. - Port Washington, NY (Lic. No. 1256, STN No. 103753)

Allermed Laboratories, Inc. - San Diego, CA (Lic. No. 467, STN No. 102211)

Nelco Laboratories, Inc. - Deer Park, NY (Lic. No. 459, STN No. 102192)

Allergy Laboratories, Inc. - Oklahoma City, OK (Lic. No. 103, STN No. 101376)

Table 1. Use in Diagnosis and Treatment Addressed in Literature
table 1 use in diagnosis and treatment addressed in literature21
Search Strategy

PubMed: Acer negundo allergens; Boxelder allergens

Google: box elder allergy; box elder allergy adverse; box elder allergen; box elder allergen adverse; same search results performed for Acer negundo

Table 1. Use in Diagnosis and Treatment Addressed in Literature
table 1 use in diagnosis and treatment addressed in literature22
Nomenclature

According to ITIS, the scientific name, Acer negundo, is correct and current. Common names are ashleaf maple, box elder, boxelder maple, California boxelder, . . . The Acer genus is found in the Aceraceae family. PLANTS database states that Acer negundo is in the Aceraceae Family or Maple Family and lists five varieties of A. negundo that have the common name, . . .

Table 1. Use in Diagnosis and Treatment Addressed in Literature
table 1 use in diagnosis and treatment addressed in literature23
Published Data

Panel 1 (pg 3157) cites two case studies of skin test diagnosis for maple pollen extracts (Ref. 153 and 154) but did not specify their genus or species.

PMID 12221895 describes how patterns of cross-sensitivity to tree pollens were identified. . . The following tree pollens were examined by modified radioallergosorbent test (RAST): oak, birch, beech, poplar (populus deltoides), . . The highest prevalence of hypersensitivity was for (birch, oak, and maple). . .

PMID 3944375 reports on the use of polymerized ragweed (PRW), polymerized grasses (IPG) and polymerized trees (IPT) for immunotherapy in ragweed patients. . . All patients had (+ SPT to one or) more of the following 1:10 tree extracts: white oak, elm, or box elder. . . The patient's immunotherapy was administered in 12 weekly visits during the spring and summer of 1983. Of the 16 recruited patients, 10 were prick positive to box elder, 13 to elm, and 14 to oak. . . In terms of Safety, . . there were no systemic reactions in this group of patients. . .

Table 1. Use in Diagnosis and Treatment Addressed in Literature
slide25
Product: 557 - Plants and Plant Parts, Jute Corchorus sp.

PubMed: jute; jute allergy; jute allergen; jute immunotherapy; jute corchorus

Google: jute corchorus allergy; jute corchorus allergy adverse; jute corchorus

allergen; jute corchorus allergen adverse

Recommended Scientific NameCorchorus, (species to be specified)

Manufacturers of this Product

(Refer to published database)

Table 4. - Non-Standardized Allergenic Extracts: Minimal or No Literature Relating to Use in Diagnosis and Treatment
slide26
Search Strategy

PubMed: jute; jute allergy; jute allergen; jute immunotherapy; jute corchorus

Google: jute corchorus allergy; jute corchorus allergy adverse; jute corchorus

allergen; jute corchorus allergen

Nomenclature

According to the USDA PLANTS database, there are 9 species of Corchorus.

According to ITIS, there is one variety and eight species of Corchorus. The

Corchorus genus is found in the Tiliaceae family.

Parent Product

557 - Plants and Plant Parts, Jute Corchorus sp.

Published Data

No supportive data were identified.

Table 4. - Non-Standardized Allergenic Extracts: Minimal or No Literature Relating to Use in Diagnosis and Treatment
slide27
Table 4. - Non-Standardized Allergenic Extracts: Minimal or No Literature Relating to Use in Diagnosis and Treatment
internal review determinations 1269 products reviewed28
Table 1. Use in Diagnosis and Treatment Addressed in Literature (480)

Table 2. Foods: Use in Diagnosis Addressed in Literature (134)

Table 3. Non-food: Use in Diagnosis Addressed in Literature (73)

Table 4. Minimal or No Literature Relating to Use in Diagnosis and Treatment (566)

Table 5. Potential Safety Issues (16)

Internal review determinations(1269 products reviewed)
internal review compared to panel 1 and 2
Internal review compared to Panel 1 and 2

Internal evaluations of Panel 1 products

Panel 1 category

Diagnosis and treatment addressed in the literature (Percent)

Internal evaluations of Panel 2 products

Panel 2 category

summary
The current internal panel reviewed 1269 non-standardized allergenic

products. Each was placed into one of five categories:

Table 1. Use in Diagnosis and Treatment Addressed in Literature (480)

Table 2. Foods: Use in Diagnosis Addressed in Literature (134)

Table 3. Non-food: Use in Diagnosis Addressed in Literature (73)

Table 4. Minimal or No Literature Relating to Use in Diagnosis and Treatment (566)

Table 5. Potential Safety Issues (16)

Summary
today s presentations31
Background

Allergenics efficacy reviews

Panel 1, 21 CFR 601.25 (1974-1979)

Panel 2, 21 CFR 601.26 (1982-1983)

Current evaluation process (2003-2011)

Safety of allergenic extracts

Assessments

Next steps

Today’s presentations