www.bioworld.com/articles/454466
FDA Submissions, Approvals And Other Actions: February 2007
March 12, 2007
| Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
| AUTOIMMUNE | ||||
| Abbott Laboratories (NYSE:ABT) | Humira (FDA-approved) | Adalimumab; fully human antibody designed to block TNF- alpha | Moderately to severely active Crohn's disease | FDA approved Humira as a treatment for reducing the signs and symptoms, and inducing and maintaining clinical remission in adults who have had an inadequate response to conventional therapy (2/27) |
| CANCER | ||||
| Pfizer Inc. (NYSE:PFE) | Sutent (FDA-approved) | Sunitinib malate; a multiple-receptor tyrosine kinase inhibitor | Advanced renal cell carcinoma | FDA approved new labeling to include first-line treatment (2/8) |
| Pharmacyclics Inc. (PCYC) | Xcytrin | Motexafin gadolinium; small molecule from the texaphyrin class designed to induce apoptosis | Brain metastases due to non-small-cell lung cancer | FDA rejected the NDA because the trials did not demonstrate statistically significant differences between treatment arms in the prespecified endpoints (2/21) |
| Pro- Pharmaceuticals Inc. (AMEX:PRW) | Davanet | A carbohydrate polymer, composed of mannose and galactose (galactomannan) | Cancer | Began filing NDA as a treatment in combination with 5-fluorouracil (2/7) |
| Seattle Genetics Inc. (SGEN) | SGN-33 | Lintuzumab; a humanized monoclonal antibody targeting CD33 | Acute myeloid leukemia | FDA granted orphan drug designation (2/13) |
| Spectrum Pharmaceuticals Inc. (SPPI) and GPC Biotech AG (Germany; GPCB) | Satraplatin | Oral platinum compound | Prostate cancer | GPC completed its submission of the rolling NDA (2/19) |
| CARDIOVASCULAR | ||||
| Aastrom Biosciences Inc. (ASTM) | Tissue Repair Cells | Consist of a mixture of stem and progenitor cell populations, produced from a small amount of bone marrow taken from the patient | Dilated cardiomyopathy | FDA granted orphan drug designation (2/1) |
| Cardiome Pharma Corp. (Canada; CRME) and Astellas Pharma US Inc. | Vernakalant hydrochloride | Intravenous formulation | For the acute conversion of atrial fibrillation | FDA accepted for review the NDA (2/20) |
| EPIX Pharmaceuticals (EPIX) | Vasovist | Blood-pool imaging agent | To visualize vascular disease | EPIX filed a formal appeal with the FDA seeking approval of Vasovist, following three denials by the agency (2/28) |
| Gilead Sciences Inc. (GILD) | Ambrisentan | Once-daily treatment | Pulmonary arterial hypertension | FDA granted priority review for the NDA (2/20) |
| ZymoGenetics Inc. (ZGEN) | rhThrombin | Recombinant human thrombin | Hemostasis during surgery | FDA accepted for review the BLA (2/19) |
| CENTRAL NERVOUS SYSTEM | ||||
| New River Pharmaceuticals Inc. (NRPH) and Shire plc (UK) | Vyvanse | Once-daily treatment that consists of d-amphetamine, covalently linked to l- ysine, a naturally occurring amino acid that is quickly absorbed from the gastrointestinal tract and converted to d-amphetamine | Attention deficit hyperactivity disorder | FDA approved Vyvanse (2/26) |
| INFECTION | ||||
| Advancis Pharmaceutical Corp. (AVNC) | Amoxicillin PULSYS | Amoxicillin formulation delivered with once-daily pulsatile Pulsys technology | Pharyngitis | Company received a refusal to file letter from the FDA for the once-daily NDA; the application did not include a proposed commercial batch record or a detailed commercial process description with process parameters and in-process controls (2/14) |
| Emergent BioSolutions Inc. (NYSE:EBS) | BioThrax | Anthrax vaccine absorbed | Postexposure prophylaxis against anthrax infection | FDA granted fast-track designation (2/12) |
| Theravance Inc. (THRX) | Tevavancin | Lipoglycopeptide; bactericidal injectable antibiotic | Complicated skin and skin structure infections caused by Gram-positive organisms | FDA accepted the NDA (2/21) |
| ViroPharma Inc. (VPHM) | Maribavir | Benzimidazole compound; oral inhibitor of cytomegalovirus | To prevent cytomegalovirus viremia | Received orphan drug designation from the FDA (2/7) |
| MISCELLANEOUS | ||||
| BioMimetic Therapeutics Inc. (BMTI) | rhPDGF-BB | Recombinant human platelet derived growth factor | Osteonecrosis of the jaw | FDA designated rhPDGF-BB an orphan drug (2/21) |
| Hana Biosciences Inc. (HNAB) | Zensana | An oral spray formulation of the 5-HT3 antagonist ondansetron | To prevent nausea and vomiting as a result of chemotherapy | FDA approval will likely be delayed because stability studies detected small amounts of precipitated material in scale-up batches of Zensana (2/21) |
| Kuros Biosurgery AG (Switzerland) | I-040302 | Bone-repair product | Solitary bone cysts | FDA granted orphan drug designation (2/22) |
| Ortec International Inc. (OTC BB: OTCI) | OrCel | Tissue-engineered product | Venous leg ulcers | Filed a pre-market approval supplement application (2/26) |
| | ||||
| 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; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board | ||||