FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING
QUESTIONS TO THE COMMITTEE
March 19, 2002
Holiday Inn, Two Montgomery Village Avenue, Gaithersburg, MD
NDA 21-245, Picovir™ (pleconaril), ViroPharma Incorporated, proposed for treatment of acute picornaviral upper respiratory illness (common cold) in adults
Please consider the following points as you discuss this issue:
2. Please discuss the safety of pleconaril in adult patients with symptoms of acute VRI.
Please consider the following points as you discuss this question:
3. Based on your discussion, does the safety and efficacy profile of pleconaril support its approval for treatment of VRI in adults?
4. If the answer to question 3 is yes, are there any safety or efficacy issues that you would like to see addressed in product labeling? This may include issues in specific sub-populations and/or any risk communication strategies.
5. If the answer to question 3 is no, please discuss what additional data should be provided to establish pleconarilís safety and efficacy.
6.Should you agree that the safety and efficacy of pleconaril have been established, please comment on the applicantís proposed phase 4 studies, and provide suggestions for other types of studies (clinical and/or pharmacologic), including designs and patient populations, that should be conducted as phase 4 commitments.
7. Please discuss any additional suggestions that you have regarding the design of future clinical trials for this indication. Please include in your discussion diagnostic criteria, patient populations, endpoints, and the potential for drug interactions.