FDA Submissions, Approvals And Other Actions: March 2007
Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
CANCER | ||||
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Cell Therapeutics Inc. (CTIC) | Pixantrone | Anthracycline agent designed to have improved properties | Indolent non-Hodgkin's lymphoma | Filed SPA with the FDA for design of Phase III PIX303 trial, which is expected to test the drug in a combination regimen in 300 patients (3/13) |
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Cell Therapeutics Inc. (CTIC) | Xyotax | Paclitaxel poliglumex | Non-small-cell lung cancer | Filed SPA with the FDA for a Phase III trial comparing the combination of Xyotax and carboplatin to paclitaxel and carboplatin (3/20) |
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Dendreon Corp. (DNDN) | Provenge | Sipuleucel T; active cellular immunotherapy | Prostate cancer | FDA advisory committee voted favorably, 13-4, that there is substantial evidence of efficacy (3/29) |
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Hana Biosciences Inc. (HNAB) | Zensana | Ondansetron HCl; oral spray | To prevent nausea and vomiting associated with chemotherapy, radiation and surgery | Withdrew an NDA due to a manufacturing issue (3/23) |
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NeoPharm Inc. (NEOL) | IL13-PE38QQR | Cintredekin besudotox; agent designed to deliver bacterial cytotoxic PE38 | Recurrent glioblastoma multiforme | The FDA's Office of Oncology wants another Phase III trial before considering approval of the drug (3/29) |
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Nuvelo Inc. (NUVO) | rNAPc2 | A recombinant protein designed to interfere with the tissue factor/factor VIIa/factor Xa protease complex | First- and second-line treatment of metastatic colorectal cancer | FDA granted fast-track designations of rNAPc2 to improve progression-free survival and overall survival when added to Avastin-containing 5-fluorouracil-based regimens in first-line, and when combined with 5-FU-based chemotherapy for second-line (3/27) |
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Spectrum Pharmaceutical Inc. (SPPI) | EOquin | Apaziquone for intravesical instillation; activated by reductase enzymes found in cancer cells | Non-invasive bladder cancer | Reached agreement with FDA on the pivotal trial design, which will evaluate tumor recurrence after two years in two 562-patient trials (3/13) |
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CARDIOVASCULAR | ||||
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Alexion Pharmaceuticals Inc. (ALXN) | Soliris | Eculizumab; monoclonal antibody designed to selectively block terminal complement activation | Paroxysmal nocturnal hemoglobinuria | The FDA approved the product for treating PNH patients to reduce hemolysis; PNH is a rare, disabling blood disorder (3/16) |
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Omrix Bio-pharmaceuticals Inc. (OMRI) | Evicel (FDA-approved) | A second-generation liquid fibrin sealant | General hemostasis in surgery | Submitted a sBLA for the expanded label (3/8) |
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Speedel Group (Switzerland; SWX:SPPN) and Novartis AG (Switzerland) | Tekturna | Aliskiren; once daily oral tablet | High blood pressure | FDA approved Tekturna for use as a monotherapy and with other anti-hypertensives (3/6) |
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ZymoGenetics Inc. (ZGEN) | rhThrombin | Recombinant human thrombin administered by a spray device | To control bleeding during surgery | FDA will not require additional trials, shortening the development timeline by about 18 months; the spray would follow approval of the company's BLA for rhThrombin (3/7) |
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CENTRAL NERVOUS SYSTEM | ||||
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Endo Pharmaceuticals Holdings Inc. (ENDP) and Vernalis plc (UK; LSE:VER) | Frova (FDA-approved) | Frovatriptan; 5HT 1B/1D agonist | Menstrually related migraine | The FDA said it would need three more months to review supplemental NDA that was filed in August; no new data are needed; the review is expected to be completed by Aug. 19 (3/16) |
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Pozen Inc. (POZN) | Trexima | Combination of sumatriptan succinate and naproxen sodium in a single tablet | Acute migraine | FDA accepted for review the amended response to an approvable letter (3/23) |
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Valeant Pharmaceuticals Inc. (NYSE:VRX) | Permax (FDA-approved) | Pergolide; dopamine agonist | Parkinson's disease | Company withdrew Permax from the market because it can seriously damage heart valves (3/29) |
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INFECTION | ||||
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Advanced Life Sciences Holdings Inc. (ADLS) | Cethromycin | Second-generation ketolide antibiotic | Anthrax infection | The FDA granted orphan designation to the product for the prophylactic treatment of patients exposed to inhalation anthrax (3/14) |
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Advancis Pharmaceutical Corp. (AVNC) | Amoxicillin Pulsys | Amoxicillin formulation delivered with once-daily pulsatile Pulsys technology | Pharyngitis/tonsillitis | Resubmitted its NDA for a once-daily product for treating adolescents and adults; this follows a refusal-to-file letter from the FDA in February, requesting more information on commercial manufacturing processes (3/23) |
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Gilead Sciences Inc. (GILD) and F. Hoffmann-La Roche Ltd. (Switzerland) | Tamiflu (FDA-approved) | Oseltamivir phosphate | Influenza | Roche filed an sNDA to market 30-mg and 45-mg pediatric doses of Tamiflu, which is currently available in a 75-mg capsule for adults and a liquid suspension formulation for children (3/9) |
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MISCELLANEOUS | ||||
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Amgen Inc. (AMGN) | Aranesp and Epogen (both FDA-approved) | Red-blood cell boosters; ertyhropoietin products | Anemia in chronic kidney failure and cancer | FDA is requiring a new black box warning on the labels letting patients know of death risks plus chances of cardiovascular events and tumor growth when used off-label (3/9) |
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Cangene Corp. (Canada; TSX:CNJ) | Accretropin | A recombinant human growth hormone product | Growth failure in children with growth hormone deficiency and short stature associated with Turner syndrome | Received an approvable letter from the FDA, which requested additional support data regarding manufacturing processes (3/12) |
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DOR BioPharma Inc. (OTC BB:DORB) | orBec | Oral formulation of beclomethasone dipropionate | To prevent graft-vs.-host disease | Received clearance from the FDA to conduct a Phase II trial with 138 patients (3/26) |
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Insmed Inc. (INSM) | Iplex (FDA-approved) | Composition of insulin-like growth factor-1 and its primary binding protein, BP3 | Short stature | The settlement of a patent fight with Tercica Inc. resulted in the removal of Iplex from the market, clearing the path for Tercica's drug Increlex; Insmed also is withdrawing its Iplex marketing application in Europe (3/7) |
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Novartis AG (Switzerland) | Zelnorm | Tegaserod maleate | Irritable bowel syndrome with constipation and chronic constipation | Novartis agreed to an FDA request to remove it from the market due to an increased risk of serious cardio-vascular adverse events associated with the drug (3/30) |
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Nuvo Research Inc. (Canada; TSX:NRI) | Pennsaid | A topical non-steroidal anti-inflammatory drug | Osteoarthritis | Company learned after an FDA meeting that an additional Phase III is not needed to satisfy questions in an approvable letter; the company expects to file a response in the fourth quarter (3/8) |
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Progenics Pharmaceuticals Inc. (PGNX) and Wyeth Pharmaceuticals | MNTX receptors | Methylnaltrexone; agent designed to block peripheral opioid | Opioid-induced constipation | Progenics and Wyeth filed an NDA for a subcutaneous version (3/30) |
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. | ||||
LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange | ||||