FDA Submissions, Approvals And Other Actions: May 2006
Company* | Product | Description | Indication | Status (Date) |
AUTOIMMUNE | ||||
Centocor Inc. | Remicade (FDA-approved) | Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha | Pediatric Crohn's disease | The FDA approved the drug for use in pediatric patients with moderately to severely active disease who have inadequately responded to conventional therapy (5/19) |
CANCER | ||||
Accentia Bio- | BiovaxID | Personalized vaccine; tumor antigen conjugated to KLH administered with GM-CSF | Follicular non- Hodgkin'slymphoma | Accentia's majority-owned sub- sidiary, Biovest International Inc., was granted fast-track status for the product by the FDA (5/11) |
Adventrx | CoFactor | Form of folic acid designed to enhance the effects of 5-FU | Metastatic colorectal cancer | Reached agreement on SPA with FDA for Phase III trial to compare drug to leucovorin as part of first- line regimens (5/22) |
Bioniche Life | Urocidin | Mycobacterial cell wall- DNA complex | Bladder cancer | The FDA granted fast-track designation to the product for treating non-muscle invasive bladder cancer in BCG-refractory patients (5/4) |
Celgene | Thalomid (FDA-approved) | Thalidomide | Multiple myeloma | The FDA granted accelerated approval to sNDA for use with dex- amethasone for treating newly diagnosed MM (5/25) |
Cell Genesys | GVAX | Vaccine comprising non- patient-specific tumor cells modified to secrete GM-CSF; an immunotherapy | Prostate cancer | The FDA granted fast-track designation in that indication, for which Phase III trials are ongoing (5/10) |
Genentech | Avastin | Bevacizumab; antibody designed to inhibit vascular endothelial growth factor | Advanced breast cancer | Submitted supplemental BLA with FDA seeking approval for use with taxane chemotherapy in first-line metastatic disease (5/25) |
Hana | Talotrexin (PT-523) | Non-classical antifolate; analogue of aminopterin | Acute lymphoblastic leukemia | The FDA granted orphan designation to the product in that indication (5/22) |
Marshall | Phenoxodiol | Agent designed to induce apoptosis by removing intracellular proteins XIAP and c-FLIP | Advanced ovarian cancer | Reached agreement with FDA on pivotal Phase III OVATURE trial that will assess restoration of sensitivity to carboplatin (5/16) |
MGI Pharma | Dacogen | Decitabine for injection; a hypomethylating agent | Myelodysplastic syndromes | The FDA approved the product and gave it a broad label for treating MDS; MGI will market the drug (5/3) |
Novelos | NOV-002 | Oxidized glutathione- based compound; chemo- protectant and immuno-modulator | Advanced non-small- cell lung cancer | Reached agreement with FDA on SPA for pivotal Phase III trial to evaluate drug in first-line chemo- therapy regimen (5/30) |
Oxford | TroVax | Vaccine that delivers an antigen (5T4) using a poxvirus vector | Renal cell carcinoma | Reached agreement on SPA with FDA for Phase III TRIST trial, which will evaluate vaccine with first-line standard therapy (5/12) |
OxiGene Inc. | Combrestatin A4 Prodrug | Vascular-targeting agent designed to block the flow of blood to a tumor | Ovarian cancer | The FDA granted orphan designation to the product in that indication (5/15) |
CARDIOVASCULAR | ||||
Cardiome | RSD1235 | Intravenous formulation of drug designed to selectively block ion channels in the heart | Atrial fibrillation | The FDA issued a refusal to file response to NDA that was filed in March by Cardiome partner Astellas Pharma US Inc. (5/31) |
CENTRAL NERVOUS SYSTEM | ||||
Cephalon | Nuvigil | Armodafinil; single-isomer formulation of the active ingredient in Provigil (modafinil) | Excessive sleepiness | FDA issued approvable letter for treating sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder; approval is contigent only on product labeling (5/1) |
Neurocrine | Indiplon | Capsule formulation of a non-enzodiazepine agent that targets the GABA-A receptor | Insomnia | The FDA said the 5-mg and 10-mg capsule formulations of the drug were approvable; a re-analysis of data was requested (5/16) |
Neurocrine | Indiplon | Extended-release tablet formulation of a non- enzodiazepine agent that targets the GABA-A receptor | Insomnia | The FDA said the agent was not approvable; it asked for a re-analysis of certain safety and efficacy data, likely requiring additional clinical data (5/16) |
NeuroHealing | NH001 | Dopaminergic agonist | Brain injury | The FDA granted orphan designation to the product for treating patients in a vegetative or minimally conscious state (5/25) |
INFECTION | ||||
Caprion | Shigamabs | Intravenous agent consisting of the monoclonal antibodies caStx1 and caStx2 | Shigatoxin- producing bacterial infections | The FDA granted fast-track designation to the product in that indication, for which a pivotal trial is being planned (5/10) |
Coley | Actilon (CPG 10101) | Agent designed to target and stimulate Toll-like receptor 9 | Hepatitis C | The FDA granted fast-track status to the product for treating refractory patients chronically infected with HCV (5/17) |
Cubist | Cubicin (FDA-approved) | Daptomycin for injection; a bactericidal antibiotic | S. aureus bacteremia and endocarditis | The FDA approved supplemental application for the new indication of treating bloodstream infections (5/25) |
Nektar | ABIP | Amphotericin B inhalation powder | Pulmonary fungal infections | The FDA granted fast-track status to the product for prevention of funal infections in patients at risk for aspergillosis (5/22) |
MISCELLANEOUS | ||||
Adolor Corp. | Entereg | Alvimopan capsules; mu opioid antagonist | Post-operative ileus | The FDA accepted as complete the response to the July 2005 NDA approvable letter; the PDUFA date is Nov. 9(5/31) |
Aradigm | -- | Aerosolized, liposomal formulation of ciprofloxacin | Cystic fibrosis | The FDA granted orphan designation to the product in that indication (5/9) |
CollaGenex | Oracea | Capsule formulation of doxycycline | Rosacea | The FDA approved the drug for treating inflammatory lesions of rosacea in adult patients (5/30) |
Dyax Corp. | DX-88 | Recombinant small protein designed to inhibit human plasma kallikrein | Hereditary angioedema | The FDA said more clinical data would be needed than was planned, likely setting back the development timeline (5/15) |
NPS | Preos | Recombinant human parathyroid hormone | Osteoporosis | The FDA said NPS should conduct another clinical trial to address the hypercalcemia issue raised in March 2006 approvable letter (5/2) |
Regeneron | IL-1 Trap | Agent designed to attach to and neutralize interleukin-1 | CIAS1-associated periodic syndromes | The FDA granted fast-track designation to the product for treating chronic inflammation in patients with CAPS, a spectrum of rare genetic disorders (5/31) |
Threshold | TH-070 | lonidamine; an indazole-3-carboxylic acid | Benign prostatic hyperplasia | The FDA placed a hold on Phase II program due to abnormalities seen in liver enzyme levels; the company must provide additional information to the FDA (5/11) |
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; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange. | ||||