www.bioworld.com/articles/451627
FDA Submissions, Approvals And Other Actions: July 2007
Aug. 13, 2007
| Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
| AUTOIMMUNE | ||||
| Targeted Genetics Corp. (TGEN) | tgAAC94 | Uses an adeno-associated virus vector to deliver the gene encoding a soluble form of the receptor for TNF-alpha | Inflammatory arthritis | FDA placed a hold on the development program following a serious adverse event in one subject (7/25) |
| CANCER | ||||
| GPC Biotech AG (Germany; GPCB), Pharmion Corp. (PHRM) and Spectrum Pharmaceuticals Inc. (SPPI) | Orplatna | Satraplatin; oral platinum compound | Hormone- refractory prostate cancer | The Oncology Drugs Advisory Committee voted 12-0 to recommend that the agency wait for the overall survival results, expected the end of this year (7/24); company withdrew the NDA (7/30) |
| Spectrum Pharmaceuticals Inc. (SPPI) | ISO-Vorin | Levofolinic acid, LFA; the pure active isomer of calcium lecuovorin | Osteogenic sarcoma | Completed the filing of an amendment to the NDA for ISO-Vorin; it addresses questions regarding the chemistry manufacturing and control section of the filing (7/2) |
| CARDIOVASCULAR | ||||
| Lev Pharmaceuticals Inc. (OTC BB:LEVP) | Cinryze | A C1 inhibitor | Hereditary angioedema | Lev submitted a BLA for its C1 inhibitor (7/31) |
| CENTRAL NERVOUS SYSTEM | ||||
| Neurochem Inc. (NRMX) | Alzhemed | Tramiprosate | Alzheimer's disease | FDA granted fast-track status (7/24) |
| ProEthic Pharmaceuticals Inc.* | PRO-513 | Uses the company's Dynamic Buffering Technology to enhance the absorption of the active ingredient diclofenac potassium | Migraines | Submitted an NDA (7/2) |
| Shire plc (UK) | Vyvanse | Lisdexamfetamine dimesylate | Attention deficit hyper-activity disorder in adults | Submitted an sNDA (7/2) |
| DIABETES | ||||
| ImmunoMod LLC* | Agent for protecting beta cell function in early stage diabetic youth | Type I diabetes | Received an FDA Orphan Drug Grant award and is beginning its first clinical trial (7/25) | |
| INFECTION | ||||
| Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN) | Ceftobiprole | Broad-spectrum, anti MRSA cephalosporin antibiotic | Complicated skin and skin structure infections | U.S. regulatory authorities accepted the NDA (7/18) |
| BioMarin Pharmaceutical Inc. (BMRN) | Kuvan | Sapropterin dihydro-chloride | Phenylketonuria | Received priority review status from the FDA for its NDA for Kuvan (7/26) |
| Hoffmann-La Roche Inc. | Tamiflu (FDA-approved) | Oseltamivir phosphate capsules | Influenza | FDA approved an sNDA to market Tamiflu in 30-mg and 45-mg doses (7/3) |
| Idenix Pharmaceuticals Inc. (IDIX) | NM283 | Valopicitabine; nucleoside inhibitor | Hepatitis C virus | FDA ordered a clinical hold of the Phase II drug due to gastrointestinal side effects (7/13) |
| Tibotec Pharmaceuticals Ltd. (Ireland; unit of Johnson & Johnson) | TMC125 | Etravirine | HIV | Submitted an NDA (7/18) |
| MISCELLANEOUS | ||||
| Allergy Therapeutics plc (UK; PK:AGYTF) | Pollinex Quattro | Hay fever allergy vaccine | Hay fever | FDA put the U.S. trial on hold after one subject suffered an adverse reaction; the company will have to conduct a new trial (7/24) |
| Humanetics Corp.* | BIO 300 | A small, single molecular agent | Acute radiation syndrome | FDA granted orphan drug designation (7/20) |
| MGI Pharma Inc. (MOGN) and Helsinn Healthcare SA (Switzerland) | Aloxi | Palonosetron hydrochloride injection | To prevent postoperative nausea and vomiting | FDA accepted for filing the sNDA (7/9) |
| Neurochem Inc. (NRMX) | Kiacta | Eprodisate | AA amyloidosis | FDA issued a second approvable letter, requesting a new efficacy trial and further pharmacokinetic studies (7/18) |
| QLT Inc. (QLTI) | Aczone (FDA-approved) | Dapsone gel formulated with SMP technology | Acne | FDA accepted for filing and review its labeling supplement for Aczone, requesting the removal of the glucose-6-phosphate dehydrogenase screening and blood monitoring requirements from its current label (7/23) |
| Vivus Inc. (VVUS) | Evamist | A metered-dose trans-dermal estradiol spray | Moderate to severe vaso-motor symptoms due to menopause | Won FDA approval (7/30) |
| Wyeth Pharmaceuticals | Pristiq | Desvenlafaxine; a serotonin-norepinephrine reuptake inhibitor | Moderate to severe vaso-motor symptoms | FDA issued an approvable letter (7/24) |
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. | ||||
| OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange | ||||