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U.S. Department of Health and Human Services

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January 28, 2014: Allergenic Products Advisory Committee Meeting Errata

Errata, FDA Briefing Document, Allergenic Products Advisory Committee, Ragwitek (January 28, 2014)

  1. Section 2.0, page 4, second bullet: “P06081…196 subjects” change 196 to 203

     

  2. Section 2.0, page 5, first bullet: “P05234…784 subjects” change 784 to 783

     

  3. Section 2.0, page 5, second bullet: “P05751…914 subjects” change 914 to 913

     

  4. Table 1, page 6, first row, last column: “7 days…” change 7 to 28. Treatment duration in this study was 28 days. There was a 7 day lag between starting sequential cohorts.

     

  5. Table 2, page 7: This table should be replaced by the table below from the Merck APAC briefing document (Table 5, page 35). Table 2 in the FDA APAC document reflects Daily Medication Scoring used for pediatric studies in the GRASTEK program.

 

RHINOCONJUNCTIVITIS
STEP AR/ARC Rescue Medication Score/Dose Unit Maximum Daily Score
1 Loratadine RediTabs tablet 10 mg – 1 tablet QD (≥ 18 yr.) 6 (per tablet or 10 6
  Olopatadine   hydrochloride   0.1% ophthalmic solution -1 drop in the affected eye BID 1.5 (per drop)  
2 Mometasone furoate monohydrate nasal spray 50mcg - 2 sprays in each nostril QD (≥12 yr.) 2 (per spray) 6
3 Prednisone tablet 5 mg (Day 1 - 1 mg/kg/day, Max 50 mg/day) 1.6 (per tablet) 8
Prednisone tablet 5 mg (Day 2+ - 0.5 mg/kg/day, Max 25 mg/day) 1.6 x 2 (per tablet) 16a
Maximum rhinoconjunctivitis Daily Medication Score 36

 

  1. Page 7, last paragraph: Revise first sentence to read “Key secondary endpoints are the DSS and DMS over the peak of ragweed season, and the TCS and DSS over the entire ragweed season. DMS over the entire ragweed season was an additional secondary endpoint. (Note: DMS over the entire season was not a “key” secondary endpoint)

     

  2. Section 4.1, page 10, second paragraph: “Study RT-01…seven days” Change seven to 28 (see bullet 4 above).

     

  3. Section 4.1, page 10, fourth paragraph: “Subjects using low dose…were not excluded…” Subjects using ICS were excluded from study P06081.

     

  4. Section 4.1.2, page 12, second paragraph: In the sentence beginning “Treatment-related adverse events…” change 1707 to 1057 to reflect the subjects exposed to 12 Amb a 1-U, change 56.5% to 45.6% and 37.6% to 20.5% to reflect the appropriate percentages for treatment-related events. The current percentages are for treatment-emergent events.

     

  5. Section 4.1.2, page 13, first paragraph: In the sentence beginning “Treatment-related adverse events…” change 80.6% to 61.2% and 68.4% to 25.4% to reflect the appropriate percentages for treatment-related events. The current percentages are for treatment emergent events.