FDA Calendar Updates: ABT, AFFY, AZN, LLY, MELA, PFE, SOMX, VPHM Print E-mail
Thursday, 04 June 2009 15:06

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of about 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 additional 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 6/4/09, Abbott Labs (NYSE:ABT) and AstraZeneca (NYSE:AZN) announced that the companies have submitted a New Drug Application (NDA) to the FDA for an investigational compound to treat mixed dyslipidemia, a combination of two or more lipid abnormalities including high LDL (bad) cholesterol, high triglycerides and low HDL (good) cholesterol. The NDA submission for this investigational compound, containing the active ingredients of CRESTOR (rosuvastatin) and TRILIPIX (fenofibric acid), is supported by data from multiple studies, including efficacy and safety studies with the 5mg, 10mg and 20mg doses of rosuvastatin combined with fenofibric acid. Pending approval of the NDA, the treatment will be marketed as CERTRIAD.

On 6/4/09, Somaxon Pharma (NASDAQ:SOMX) announced that it has resubmitted its New Drug Application (NDA) to the FDA for Silenor (doxepin) for the treatment of insomnia in response to a 2/25/09 Complete Response Letter (CRL) and following a 4/6/09 meeting with the FDA. The resubmission includes additional statistical analyses of the Company’s clinical data relating to the durability of subjective sleep maintenance efficacy. It also includes the results of the Company’s completed clinical trial of doxepin that evaluated the potential for electrocardiogram (ECG) effects. The results of that clinical trial demonstrated that Silenor had no effect on QT interval prolongation when administered at 6 mg or under exaggerated exposure conditions of 50 mg. The FDA has indicated that the review cycle for the resubmission will be six months (a Class 2 Review designation) for an estimated decision date of 12/4/09 on the Silenor NDA resubmission.

Eli Lilly (NYSE:LLY): On 6/3/09, LLY announced that it resubmitted its supplemental New Drug Application (sNDA) for Cymbalta (duloxetine HCl) for the management of chronic pain to the FDA. Lilly's resubmission is based on a recently completed study in chronic pain due to osteoarthritis, the extension phase of a chronic low back pain study and previously completed studies in pain due to osteoarthritis and chronic low back pain. The application is supported by studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgia. Lilly originally submitted the sNDA in the second quarter of 2008 but withdrew the application in November 2008 following discussions with the FDA primarily about statistical methodology and

study design.

Electro-Optical Sciences (NASDAQ:MELA): On 6/4/09, MELA announced the submission to the FDA of its Premarket Approval (PMA) application for MelaFind, a non-invasive, point-of-care instrument to assist in the early diagnosis of melanoma, the leading cause of death from skin cancer. Positive top line data from the MelaFind pivotal study, the largest prospective clinical study ever conducted in melanoma detection, were announced in February 2009 and subsequently presented at several major international dermatology meetings in March and

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May. The Company's final analysis of the data demonstrated that for all subgroups analyzed, the sensitivity of MelaFind was greater than 95% (lower confidence bound) and MelaFind specificity was statistically significantly higher than that of study clinicians. As announced previously, the FDA has granted expedited review (six months) for the MelaFind PMA, resulting in an estimated decision date deadline of 12/4/09.

Affymax (NASDAQ:AFFY): On 6/3/09, AFFY announced that the independent Data Monitoring Committee (DMC), which provides oversight for the Phase 3 program for Hematide, has completed another review and

has informed the company that the cumulative safety data generated thus far from the EMERALD and PEARL Phase 3 trials support continuation of the studies. In the Phase 3 program, Hematide is being evaluated to treat anemia in chronic renal failure patients on dialysis and not on dialysis. The Phase 3 program, which consists of four trials, was initiated in October 2007. Affymax announced that enrollment was complete in all four Phase 3 trials in November 2008 and reiterated its expectation for a NDA submission in 2010.

On 6/4/09, ViroPharma (NASDAQ:VPHM) announced that it received a Complete Response Letter (CRL) from the FDA, which requested that the Company conduct another clinical trial of its drug Cinryze before it will consider a new approval to expand use of the drug. Cinryze treats hereditary angioedema (HAE), a genetic disease that can cause dangerous swelling in the throat and extremities. The drug is already approved as a routine preventive treatment for angioedema attacks, and VPHM is trying to gain additional marketing approval for the drug as a treatment for acute attacks. The FDA wants a new clinical trial because the placebo-controlled study included in the Company's application was not strong enough. VPHM reported that the FDA did not mention any safety concerns for Cinryze in the CRL and the Company did not specify how long a new study might take.

On 6/3/09, Pfizer (NYSE:PFE) Animal Health announced that the FDA approved the first canine cancer therapy in the U.S., Palladia (toceranib phosphate), which was developed by the Company to treat mast cell tumors in dogs. PFE expects to make the product available for purchase early next year. On the same day, Merck (NYSE:MRK) announced that it was exploring strategic options for the sale of its animal health division, which includes a joint venture (Merial) with Sanofi-Aventis (NYSE:SNY), as well as the animal health division of Schering-Plough (NYSE:SGP) as part of the two companies planned merger.

Disclosure: No positions.

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