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  PROPECIA FDA HEARING  
 
 
QUESTION 6
 
How does Finasteride affect frontal hair growth
 
ANSWER

DR. MILLER: I have a question about the efficacy frontal versus vertex. It appears that the vertex--it was clearly more efficacious on the vertex if you took hair counts. I think it was 107, and the difference in the frontal area was 59. You have fewer patients with the frontal evaluations, and yet, when patients present, the vast majority present with frontal hair loss, the vertex is a problem but not nearly the problem that the frontal loss is. So, I'd ask you why the difference in response between vertex and frontal and then, why your emphasis on vertex when the frontal is really the area that's more important.

DR. KAUFMAN: The question has to do with the relative efficacy demonstrated in the frontal hair loss study compared with the efficacy in the vertex studies. I think that the hair count data in the frontal study, as you commented, does show less of an increase from baseline or less of a large treatment effect compared with the vertex studies. But it's worth recalling that the area sampled in the frontal hair loss study is within the frontal thinning area. It is not at the anterior leading edge of active hair loss, as in the vertex study. So, there may be a sampling bias related to those two studies that impacts on the change from baseline and hair counts.

In addition, the actual baseline hair count in the frontal hair loss study was greater than it was in the vertex studies, and the data do support that the lower the hair count at baseline, the higher the increase from baseline. Now, an additional point is that we did evaluate the frontal area in all patients in the vertex pivotal study. So, all 1,553 patients participating in the pivotal vertex studies also had photographs of their scalp taken using that superior frontal view that was used, and in that analysis, using the same expert panel that reviewed vertex photographs, the efficacy in the frontal area was essentially the same in the 1,553 vertex patients as it was in the vertex area. So, I think in answer to your question, when you look at all of the data from all three trials, there is overwhelming evidence that there is efficacy in both the frontal and the vertex patients and that the vertex patients, when reviewed from the front by the global panel, demonstrate efficacy nearly equivalent to that in the vertex. And I showed you one example of that in the last patient in the vertex series at one year, where the second photograph of that patient demonstrated the efficacy seen in the frontal area, and that efficacy in the frontal area in the vertex studies was essentially the same as seen in the vertex area in those patients.

 
   
 
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