FDA Submissions, Approvals And Other Actions:July 2005
Company* | Product | Description | Indication | Status (Date) |
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CANCER | ||||
Chemokine | CTCE-9908 | Drug targeting cancer via the CXCR4 receptor | Osteogenic sarcoma | The FDA granted orphan designation to the drug, which is in Phase I trials (7/19) |
Onyx | Sorafenib (BAY 43-9006) | RAF kinase and VEGF inhibitor | Advanced kidney cancer | They completed filing of an NDA for that indication (7/11) |
OSI | Tarceva (FDA-approved) | Erlotinib HCl; small- molecule HER1/EGFR inhibitor | Advanced pancreatic cancer | The FDA accepted for review supplemental NDA for use with gemcitabine; the sNDA was filed in May (7/6) |
Neose | NE-180 | Long-acting, glyco- PEGylated erythropoietin | Chemotherapy- induced anemia | The FDA placed proposed Phase I trial on hold pending additional manufacturing and preclinical information (7/19) |
Sonus | Tocosol | Formulation of paclitaxel using Sonus' delivery system | Breast cancer | Reached agreement with FDA on SPA for pivotal Phase III trial that will compare drug to Taxol in 800 patients (7/7) |
CARDIOVASCULAR | ||||
Biopure | Hemopure | Oxygen therapeutic consisting of bovine hemoglobin | Blood loss in trauma patients | The FDA put proposed RESUS trial by the Naval Medical Research Center on hold until certain issues are addressed (7/12) |
CV | Ranexa (ranolazine) | Partial inhibitor of fatty- acid oxidation | Chronic angina | Submitted amendment to the NDA, based on results of ERICA trial; an approvable letter was issued in October 2003 (7/27) |
Encysive | Thelin | Sitaxsentan; small molecule designed to block endothelin | Pulmonary arterial hypertension | The FDA accepted the NDA filing and designated it for standard review; the NDA was filed in May (7/14) |
CENTRAL NERVOUS SYSTEM | ||||
Neurobiological | Namenda | Memantine; NMDA receptor antagonist | Alzheimer's disease | The FDA issued partner Forest Laboratories Inc. a non-approv- able letter on supplemental NDA to expand the label to include treatment of mild AD (7/25) |
Neurocrine | Indiplon | Capsule formulation of a non- enzodiazepine agent that targets the GABA-A receptor | Insomnia | The FDA accepted for review the NDA for treatment of insomnia in both adult and elderly patients (7/26) |
INFECTION | ||||
ID Biomedical | Fluviral | Influenza virus vaccine | Influenza | The FDA granted fast-track designation to the vaccine (7/12) |
Trimeris Inc. | Fuzeon (FDA-approved) | HIV fusion inhibitor; enfuvirtide | HIV | The FDA accepted the filing of a supplemental NDA seeking to include the Biojector 2000 needle-free injection device in the labeling (7/18) |
Vertex | 640385 (VX-385) | HIV protease inhibitor | HIV | Partner GlaxoSmithKline plc was granted fast-track designation from the FDA; a Phase III trial was about to get under way (7/19) |
MISCELLANEOUS | ||||
Adolor Corp. | Entereg | Alvimopan capsules; mu opioid antagonist | Post-operative | The FDA issued an approvable letter saying additional proof of efficacy was needed to support the NDA, which was filed in June 2004 (7/22) |
Alizyme plc | Renzapride | 5-HT4 receptor agonist and an antagonist at 5-HT3 receptors | Irritable bowel syndrome | Reached agreement with the FDA under an SPA for pivotal Phase III trial in up to 1,700 women with constipation- redominant IBS (7/7) |
BioDelivery | Emezine | Formulation of the approved agent prochlorperazine | Nausea and vomiting | The FDA accepted for review the NDA, which was filed in April (7/20) |
Chiron Corp. | Pulminiq | Cyclosporine inhalation solution | For use in patients getting lung transplants | The FDA said the product was approvable but that an additional trial was needed to confirm efficacy (7/15) |
Genentech | Nutropin and Nutropin AQ (both FDA- approved) | Somatropin for injection | Idiopathic short stature | The FDA approved supplemental applications for the long-term treatment of ISS (7/7) |
Genzyme | Myozyme | Recombinant human acid alpha-lucosidase enzyme | Pompe disease | Submitted a BLA to the FDA, seeking approval of the product (7/29) |
InKine | INKP-102 | New-generation sodium phosphate purgative tablet | Bowel cleansing prior to colonoscopy | The FDA accepted for filing the NDA, which was filed in May (7/26) |
NPS | Preos | Recombinant human parathyroid hormone | Osteoporosis | The FDA accepted for review the NDA for treating osteoporosis in postmenopausal women; it was filed in May (7/11) |
Santarus Inc. | Zegerid | Tablet formulation of the proton pump inhibitor omeprazole | Gastrointestinal disorders | The FDA accepted for filing the NDA, which is seeking approval of the chewable tablet formulation for treating heartburn and symptoms of other conditions (7/26) |
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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; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board. | ||||