FDA Submissions, Approvals And Other Actions: October 2006
Company* | Product | Description | Indication | Status |
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AUTOIMMUNE | ||||
Centocor Inc. | Remicade (FDA-approved) | Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha | Ulcerative colitis | The FDA approved the drug for patients with moderate to severe disease who had inadequate responses to conventional therapy (10/20) |
Human Genome | LymphoStat-B | Belimumab; human monoclonal antibody that inhibits activity of B- lymphocyte stimulator | Lupus | Reached agreement with FDA on SPA for Phase III program, which was expected to start later in 2006 (10/26) |
CANCER | ||||
Agennix Inc.* | Talactoferrin | Oral talactoferrin alfa solution | Renal cell carcinoma | The FDA granted orphan designation to the product in that indication (10/12) |
Agennix Inc.* | Talactoferrin | Oral talactoferrin alfa solution | Non-small-cell lung cancer | The FDA granted fast-track status to the product for first-line treatment of NSCLC (10/5) |
Alfacell Corp. | Onconase | Ranpirnase; cytotoxic ribonuclease | Malignant mesothelioma | Completed nonclinical section of rolling NDA submission with FDA; complete filing was expected in 2007 (10/2) |
Allos | PDX | Pralatrexate; anitfolate; dihydrofolate reductase inhibitor | T-cell lymphoma | The FDA granted fast-track status to the product in that indication, for which pivotal Phase II trials are ongoing (10/3) |
AVAX | M-Vax | Autologous, hapten- modified melanoma vaccine | Metastatic melanoma | Reached agreement with FDA on SPA for pivotal Phase III trial in up up to 387 patients with Stage IV melanoma (10/12) |
Genta Inc. | Genasense | Oblimersen sodium; inhibits function of bcl-2 protein | Advanced chronic lymphocytic leukemia | The FDA extended review period on NDA 90 days, to Jan. 27, after Genta submitted additional data (10/30) |
Genta Inc. | Genasense | Oblimersen sodium; inhibits function of bcl-2 protein | Chronic lymphocytic leukemia | Reached agreement with FDA on a trial that would evaluate the drug with fludarabine and rituximab (10/6) |
IDM Pharma | Junovan | Synthetic lipophilic derivative of the muramyl dipeptide | Osteosarcoma | Filed NDA with FDA seeking approval for treating newly diagnosed resectable high-grade osteosarcoma patients following surgical resection, in combination with chemotherapy (10/26) |
MGI Pharma | Saforis | Oral formulation of glutamine in company's delivery system | Oral mucositis in cancer patients | The FDA issued an approvable letter that requests an additional Phase III efficacy trial (10/12) |
Reata | RTA 744 | Anthracycline derivative that crosses the blood-brain barrier | Malignant gliomas | The FDA granted orphan designation to the Phase I product in that indication (10/26) |
CARDIOVASCULAR | ||||
Amgen Inc. | Aranesp (FDA-approved) | Darbepoetin alfa, a recombinant erythropoietic protein | Anemia in chronic kidney disease | FDA issued an approvable letter that requests additional data for the once-monthly dosing regimen, including an additional clinical study (10/13) |
CENTRAL NERVOUS SYSTEM | ||||
Anesiva Inc. | 4975 | Non-opioid, VR1 agonist that acts as a C-neuron anesthetic | Interdigital neuroma | The FDA granted orphan status to the product for treating those who fail conservative treatments (10/12) |
Avanir | Zenvia (formerly Neurodex) | Oral combination of dextromethorphan and an enzyme inhibitor, quinidine | Involuntary emotional expression disorder | The FDA issued an approvable letter that calls for additional safety and efficacy data (10/31) |
Memory | MEM 3454 | Nicotinic alpha-7 receptor partial agonist | Alzheimer's disease | The FDA placed a hold on proposed Phase IIa trial due to questions on toxicology data (10/16) |
Cortex | CX717 | Ampakine analogue; designed to improve brain cell signaling | Attention deficit/ hyperactivity disorder | The FDA lifted a clinical hold it had placed on trial in March, allowing company to resume trials (10/9) |
New River | NRP104 | Prodrug of amphetamine; capsule formulation | Attention deficit/ hyperactivity disorder | FDA issued an approvable letter; approval was contingent only upon final scheduling by the Drug Enforcement Administration (10/6) |
DIABETES | ||||
MacroGenics | MGA031 | Humanized, Fc-engineered anti-CD3 monoclonal antibody | Type I diabetes | The FDA granted orphan designation to the product in recent-onset Type 1 diabetes (10/10) |
INFECTION | ||||
Idenix | Tyzeka | Telbivudine; oral, once- daily nucleoside analogue | Hepatitis B | The FDA approved the product for treating chronic hepatitis B (10/25) |
Intercell AG | -- | Inactivated vaccine against Japanese encephalitis virus | Japanese encephalitis virus | Began BLA filing process with the FDA; full submission was expected in early 2007 (10/12) |
Replidyne | Faropenem medoxomil | Ester prodrug derivative of the beta-lactam antibiotic faropenem | Four adult indications | The FDA issued a nonapprovable letter calling for additional trials in all four indications: acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis and uncomplicated skin and skin structure infections (10/23) |
MISCELLANEOUS | ||||
Agennix Inc.* | Talactoferrin | Topical talactoferrin alfa gel | Diabetic foot ulcers | The FDA granted fast-track status to the product in that indication (10/5) |
Critical | -- | Controlled-release formulation of zileuton (Zyflo), a 5-lipoxygenase inhibitor | Asthma | The FDA accepted for filing the NDA that was submitted in July; the PDUFA date is May 31 (10/17) |
Indevus | Sanctura XR | Once-daily formulation of the approved product Sanctura | Overactive bladder | Filed NDA with FDA, seeking approval in that indication (10/12) |
Isolagen Inc. | Isolagen Therapy | Autologous cellular therapy | Wrinkles | Reached agreement with FDA on SPA for two pivotal Phase III trials of 200 patients each to evaluate efficacy and safety in nasolabial skin fold wrinkles (10/13) |
Vivus Inc. | EvaMist | Transdermal spray formulation of estradiol | Vasomotor symptoms associated with menopause | Filed NDA with the FDA, seeking approval in that indication (10/2) |
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Notes: | ||||
* Privately held. | ||||
BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; VSE = Vienna Stock Exchange. | ||||