Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 277 entries as of 7/23/09. 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 clinical trial results.
On 7/24/09, NeurogesX (NGSX) announced preliminary results of a short-term clinical study (Study C123) of Qutenza in patients with post-herpetic neuralgia (PHN) following pre-treatment with an FDA approved topical anesthetic. As part of the ongoing new drug application (NDA) review, the FDA requested the study to determine whether an FDA-approved topical anesthetic would provide similar tolerability to the topical agent used as a pretreatment in the clinical development program. Preliminary results of Study C123 showed the mean duration of patch application was 60.2 minutes, versus a target duration of Qutenza patch application of 60 minutes, and no patients removed the Qutenza patch prematurely.
NGSX expects to provide results from the study to the FDA prior to the PDUFA action date of 8/16/09, and the Company stated that the impact of this data submission on the Agency's timing for a decision on the NDA is not yet known. NGSX received approval on 5/21/09 to market Qutenza in the EU. Qutenza is a skin patch that is designed to locally deliver a high-concentration (8%) of the active substance capsaicin to provide sustained relief from peripheral nerve pain.
On 7/23/09, Rigel Pharma (RIGL) announced that in the TASKi3 Phase 2b clinical trial in rheumatoid arthritis (RA) patients who had failed to respond to at least one biologic treatment, the group treated with R788 (fostamatinib disodium) did not report significantly higher ACR 20, ACR 50, ACR 70 and DAS28 response rates than the placebo group at three months, and therefore, the trial failed to meet its efficacy endpoints. RIGL stated that its objective with R788 in RA is to position the product after methotrexate and before biological therapies are used, and the Company believes that this patient population represents a large market opportunity for the product.
On 7/9/09, RIGL announced that R788 produced significant clinical improvement in rheumatoid arthritis (RA) patients in the TASKi2 Phase 2b clinical trial of 457 patients treated for up to 6 months. Consistent with the previous Phase 2a clinical trial (TASKi1), the onset of effect of R788 occurred within one week after the initiation of therapy and was maintained. The most frequent adverse events were expected based on TASKi1 and appear to be manageable. The significant, early and sustained efficacy, combined with a good safety profile, supports Rigel's plans to conduct corporate partnership discussions with respect to R788 and initiate a Phase 3 clinical program with R788 in RA during 1H10 with a corporate partner.
On 7/23/09, Celgene (CELG) announced that a clinical trial known as MM-015 showed a highly statistically significant improvement in progression-free survival for patients taking Revlimid as a first-line treatment for multiple myeloma. The trial tested Revlimid in combination with the drugs melphalan and prednisone. Revlimid is currently approved for use with dexamethasone. Revlimid is currently approved for use in patients who have failed other therapies, and is currently used in the U.S. off-label in the first-line setting and CELG cannot market the drug for this purpose until approved by the FDA. CELG said results of the trial were originally expected during 2H09 and that the full data is not yet available for this study. Once the data is analyzed, CELG plans to meet with multiple regulatory agencies around the world.
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