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Vaccines, Blood & Biologics

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Regarding Rev090705fnl document Email, July 08, 2009 - Anascorp

From:                     Ko, Hon Sum

Sent:                      Wednesday, July 08, 2009 9:40 PM
To:                         Fisher, Robert
Cc:                         Jain, Nisha; Cordaro, Debbie
Subject:                 RE: rev090705fnl.doc
Robert:
 
This is a case of traditional approval. Because traditional approvals are not confined to products indicated for serious and life-threatening conditions, there is no need to have endpoints for mortality or irreversible morbidity. For instance, you can approve a drug to treat alopecia in leprosy, but the product obviously is not designed to treat the serious and life-threatening aspect of the disease, and we don't need it to, nor do we need phase 4 studies to address that, because it can't do the job.
 
There is a clear requirement for fast track drugs that the program approved for fast track addresses a serious and life-threatening aspect of the disease (see the form in BLA vol 1 after the 1st set of pre-BLA minutes). Now Bioclon never officially applied for FT. Instead, in the BLA submission, they have one page (vol 1, p.218) with two lines for justification but no request. We never even considered giving it FT or accelerated approval, although we did grant priority review, which in a sense recognizes it might be meeting an unmet medical need for a serious or life-threatening condition (SOPP 8405) at face value before conducting a review. Nevertheless, FDA's website says "Priority Review status can apply both to drugs that are used to treat serious diseases and to drugs for less serious illnesses. ......", which actually is the CDER standard. Bioclon has not discussed and we never considered accelerated approval under subpart E, which definitely requies the condition to be serious or life-threatening, and which would require Phase 4 study to validate clinical benefit in terms of survival or reversing serious morbidity.
 
Whether it actually addresses a serious and life-threatening aspect of the disease is a review issue. If its data do not support doing the job but still can support treating a less serious aspect of the disease, we do not hold up approval for treating that lesser indication, nor do we require studies to treat the serious and life-threatening aspect, unless this is the claim they still want. Then they will need to do studies to establish that indication. However, that should not really be a "requirement", because we cannot require firms to seek indications if they don't want to. Their seeking the serious indication in addition to the lesser indication is their choice.
 
I hope this is clear and if not, we can talk on Friday when I am back.
 
Hon-Sum.
_____________________________________________
From:                     Fisher, Robert 
Sent:                      Wednesday, July 08, 2009 5:12 PM
To:                          Ko, Hon Sum
Subject:                 RE: rev090705fnl.doc
 
Hi Hon Sum. I'm wondering about your comment re: morbidity and mortality. Is this a precondition to licensure, or something they would have to followup on in a phase IV study? 
 
_____________________________________________
From:             Jain, Nisha 
Sent:              Wednesday, 08 July, 2009 16:58
To:                  Ko, Hon Sum
Cc:                   Cordaro, Debbie; Fisher, Robert
Subject:         rev090705fnl.doc
 
 << File: rev090705fnl.doc >>
 
Please see my comments and edits.