FDA Calendar Updates: AMAG, PPDI, Takeda

Written by Mike Havrilla

Monday, 29 June 2009 00:00

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

On 6/29/09, AMAG Pharma (NASDAQ:AMAG) announced that it has not received an action letter from the FDA for Feraheme (ferumoxytol) Injection for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. The PDUFA action date was 6/29/09, and the FDA informed AMAG that the Agency would not take action today but expects to issue an action letter within the next few days. The FDA has not requested any additional information from AMAG, and it is the Company's understanding that there are no outstanding issues regarding the Feraheme NDA.

On 4/30/09, AMAG reported that the FDA was satisfied with observations noted during a recent inspection of the Company's manufacturing facility. AMAG also noted that a re-inspection of its manufacturing facility would not be required as a pre-requisite to FDA approval of Feraheme. AMAG has previously issued guidance on labeling discussions, which are likely to include a broad label that includes both dialysis and non-dialysis patients with CKD. On 5/12/09, AMAG announced the FDA accepted the Company's resubmission of its Feraheme (ferumoxytol injection) NDA in response to a December 2008 Complete Response Letter as a complete Class 1 (60-day review) response.

On 6/26/09, Takeda Pharma (TYO:4502) (PINK:TKPHY) received a complete response letter (CRL) from the FDA for the Company's New Drug Application (NDA) for alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise. In recent months, the FDA and Takeda have been in discussions about conducting a new clinical trial to assess the cardiovascular safety profile of alogliptin.

As previously announced on 3/6/09, the FDA informed Takeda that, although the alogliptin NDA was filed prior to the release of the December 2008 FDA Guidance evaluating cardiovascular risk in new diabetes drugs, the Agency did not believe that the amount of existing alogliptin clinical data was sufficient to meet certain statistical requirements outlined in the new guidance. Pharmaceutical Product Development (NASDAQ:PPDI) is set to receive $25 million as a milestone payment at the time of alogliptin FDA approval.

Disclosure: Long AMAG.

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