`RESEARCH
`
`APPLICA TION NUMBER:
`
`22-3 87
`
`SUMMARY REVIEW
`
`
`
`DIVISION OF CARDIO-RENAL DRUG PRODUCTS
`
`Divisional Memo
`
`United Therapeutics Review date: 28 July 2009
`
`22-387 (inhaled treprostinil for pulmonary
`
`NDA:
`hypertension)
`
`Sponsor:
`
`N. Stockbridge, M.D., Ph.D., HFD—llO
`Reviewer:
`Distribution: NDA 22-387
`
`HFD-l lO / Brum/ Karkowsky
`
`This memo conveys the Division’s recommendation to issue an approval letter for
`inhaled treprostinil for pulmonary arterial hypertension.
`
`After my previous memo (25 April 2009), the application was given a 3—month
`extension. During this time, the sponsor provided biocompatibility data for the device
`and results of a human factors study.
`
`Both responses are described in the CDRH review (signed 20 June 2009, DFSed 29
`June 2009) by Sugato De and Ronald Kaye. The biocompatibility data were considered
`adequate. The human factors study and the device itself are not considered adequate.
`On this latter, all members of the review team appear to be in agreement.
`
`The De—Kaye review concludes that a proper human factors study should be conducted
`with the next—generation device, but that these can be deferred to post—marketing
`commitments if the risks are considered small compared with the benefits. In this I
`agree, and, in consideration of the relatively benign safety profile of the experience with
`inhaled treprostinil and the less benign safety profile of its other approved routes of
`administration, I believe the current drug-device combination meets the test, and the
`review team seems adequately persuaded.
`
`Other reviews completed in the interim include a second CMC review (Cooper; 23 July
`2009) and a second CDTL memo (Karkowsky; 27 July 2009).
`
`The sponsor appears to have a reasonable plan to evolve the device, probably in several
`stages, with the worst identified problems being resolved in the first round.
`
`On this basis, I believe the product should now be approved. Labeling and post--
`marketing commitments and requirements have been negotiated.
`
`TreprostinilDivMemonoc
`
`—1—
`
`Last saved
`15:30 Tuesday, July 28, 2009
`
`
`
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`
`NORMAN L STOCKBRIDGE
`07/28/2009
`
`