`RESEARCH
`
`
`
`APPLICATION NUMBER:
`
`021825Orig1s000
`
`RISK ASSESSMENT and RISK MITIGATION
`REVIEW(S)
`
`
`
`
`
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`
`
`
`Date:
`To:
`
`Thru:
`
`October 21, 2009
`Rafel (Dwaine) Rieves, MD, Director
`Division of Medical Imaging and Hematological Products
`(DMIHP)
`Claudia Karwoski, Pharm.D., Director
`Division of Risk Management (DRISK)
`Office of Surveillance and Epidemiology (OSE)
`OSE DRISK REMS Review Team:
`Mary Dempsey, Risk Management Program Coordinator,
`DRISK
`Suzanne Berkman Robottom, Pharm.D, Risk Analyst Team
`Leader, DRISK
`Joyce Weaver, Pharm.D., Senior Drug Risk Management
`Analyst, DRISK, Scientific Lead
`
`Review of Risk Evaluation and Mitigation Strategy (REMS)
`Subject:
`Ferriprox (deferiprone)
`Drug Name(s):
`0024
`Submission Number:
`Application Type/Number: NDA 21-825
`Apopharma
`Applicant/sponsor:
`2009-354
`OSE RCM #:
`
`From:
`
`
`
`We acknowledge the Sponsor’s July 9, 2009 proposed Risk Evaluation and Mitigation
`Strategy (REMS) for Ferriprox (deferiprone). Due to deficiencies in the Ferriprox
`application, the Division of Medical Imaging and Hematological Products (DMIHP)
`plans to issue a Complete Response (CR) letter for this review cycle.
`
`At this time, we will defer comment on the Sponsor’s proposed REMS. A final review
`on the appropriate risk management strategy for deferiprone will be provided after the
`Sponsor responds to the deficiencies in the CR letter and the risk-benefit profile can be
`re-evaluated. We note that a tentative decision was made within the Agency regarding the
`risk mitigation strategy necessary to mitigate the risk of deferiprone-induced
`agranulocytosis. The Sponsor was notified in a telephone conference on August 12, 2009
`that a REMS with Elements to Assure Safe Use (ETASU) to ensure monitoring of blood
`
`
`
`1
`
`
`
`counts would likely be needed. On October 14, 2009, the Sponsor submitted a proposed
`REMS incorporating this advice. Because this REMS proposal was submitted so close to
`the November 30 goal date for the application, we will not review the submission in this
`cycle. We suggest that the CR letter include the following paragraph after the description
`of the deficiencies in the application.
`
`“Depending on the outcome of these analyses, FDA may require the submission of a Risk
`Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug
`outweigh its risks. In your response to this letter, you may wish to resubmit the REMS
`submitted October 14, 2009.”
`
`
`
`
`2
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`JOYCE P WEAVER
`10/22/2009
`
`CLAUDIA B KARWOSKI
`10/22/2009
`concur
`
`
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