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U.S. Food and Drug Administration

U.S. Food and Drug Administration. Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated. . ProHeart 6 Safety Assessment by Fort Dodge Animal Health.

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U.S. Food and Drug Administration

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  1. U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

  2. ProHeart 6Safety Assessmentby Fort Dodge Animal Health January 31, 2005

  3. Rami Cobb, BVSc (Hons.) MACVSc Vice President Pharmaceutical Research & Development Fort Dodge Animal Health

  4. ProHeart 6 Introduction • Active ingredient: moxidectin • Macrocyclic lactone • Anthelmintic agent • Dogs, horses, cattle, sheep, swine • Co-development with WHO for humans • Onchocerciasis (river blindness)

  5. ProHeart 6 Introduction • Innovative Product • A single dose provides 6 months protection from heartworm disease caused by • Dirofilaria immitis • Treats existing hookworm infections • Overcomes compliance failures associated with monthly heartworm preventives

  6. MoxidectinExtensive Toxicology Database • Receptor-mediated adverse pharmacologic/toxicologic effects not expected (new study) • Toxicology studies of up to 2 years in mice and rats and 1 year in dogs showed no adverse histologic or biochemical effects on any organ system • Exposure (AUC) of dogs to moxidectin in toxicology studies were 454-fold higher than after 2 doses of ProHeart 6 given 6 months apart (new study) • No increase in tumors in 2-year carcinogenicity studies

  7. Pre-Approval ProHeart 6 Clinical Study Results • Safety study results demonstrate • Wide margin of safety • Safe in breeding animals • Safe in unique canine populations • Ivermectin-sensitive • Heartworm positive • 100% efficacy at commercial dose • 100% efficacy in large number (84) of breeds • A total of 770 dogs were evaluated for US registration

  8. Factors Limiting Heartworm Control in US Dogs • Widespread availability of heartworm preventives has not changed the infection rates in last 10 years • 240,000 dogs in US tested positive for heartworm nationwide in 2001 • One-fifth of surveyed dog owners stopped giving their dogs the monthly oral preventive altogether

  9. ProHeart 6 Approval • Approved and marketed globally • US – June 2001 • Canada, Japan, Italy, France, Spain, Portugal, Greece, Korea • ProHeart SR 12 • Australia – October 2000 • 12 months heartworm protection • 3 times ProHeart 6 dose

  10. ProHeart 6 Market Experience • Rapid and broad acceptance by dog owners and veterinary professionals • 24% US market share • 47% Australian market share

  11. Brand Share Change2001 - 2004 Dispensed Units Source: June 2004 Doane Market Research: Heartworm Tracking Study

  12. ProHeart 12 - Australia

  13. US and Australian AER Reports USAustralia Doses sold 18,000,000 2,000,000 AER rate 2.5 1.6 (per 10,000 doses) Allergy reporting rate 1.3 0.8 (per 10,000 doses) Death reporting rate 0.3 0.1 (per 10,000 doses)

  14. ProHeart 6 Introduction • September 2004: FDAH voluntary recall of ProHeart 6 based on CVM concerns about adverse events • Data reviewed by Canadian, Australian, European, and Japanese regulatory authorities • Confirmed authority to continue marketing

  15. ProHeart 6 Epidemiological Evaluation(presented by Dr. Larry Glickman, Purdue University) • Large independent nation-wide database: • Banfield The Pet Hospital™ • Nearly 7 million “encounters” (office visits) • ProHeart 6, two heartworm preventives, vaccines were evaluated • Results demonstrate no clinically significant increase in adverse events following ProHeart 6 treatment • ProHeart 6 safety profile similar to 2 monthly heartworm preventives

  16. Re-Evaluation of AERs by FDAH(presented by Dr. David Hustead, FDAH) • Post-marketing monitoring of AERs • Overall reporting rate is low • Reporting rate is declining • Most AERs appear to be allergic and self limiting • Assignment of causality confounded by concurrent vaccinations • Varied non-allergic AERs reflect diseases often seen in dogs

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