FDA Submissions, Approvals And Other Actions: April 2006
Company* | Product | Description | Indication | Status (Date) |
| | ||||
| AUTOIMMUNE | ||||
Centocor Inc. | Remicade | Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha | Crohn's disease | The FDA accepted supplemental BLA filing and designated it for priority review (4/4) |
Pozen Inc. | PN 200 | Agent combining a proton pump inhibitor with a non- steroidal anti-inflammatory drugs | Various conditions | Reached agreement with FDA on SPA for pivotal trial, in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondyli- tis at risk for developing NSAID-associated gastric ulcers (4/20) |
Serono SA | Rebif (FDA-approved) | Interferon beta-1a | Multiple sclerosis | Submitted supplemental BLA with FDA seeking approval of a new formulation of Rebif (4/4) |
CANCER | ||||
Cephalon Inc. | CEP-701 (lestaurtinib) | Oral indolocarbazole agent that inhibits certain tyrosine kinases | Acute myeloid leukemia | The FDA granted orphan designation to the agent in that indication, for which Phase II/III trials are ongoing (4/4) |
Genentech | Avastin (FDA-approved) | Bevacizumab; antibody designed to inhibit vascular endothelial growth factor | Advanced non-small-cell lung cancer | Filed supplemental BLA seeking approval in combination with platinum- based chemotherapy for first-line treatment of advanced, non-quamous NSCLC (4/11) |
MGI Pharma | Saforis | Oral formulation of glutamine in company's delivery system | Oral mucositis in cancer patients | Filed NDA with FDA, seeking approval of the product (4/13) |
Onyx | Nexavar (FDA-approved) | Sorafenib; RAF kinase and VEGF inhibitor | Liver cancer | The FDA granted orphan designation to the product for treating hepatocellular carcinoma, or liver cancer (4/26) |
CARDIOVASCULAR | ||||
Speedel Holding | SPP100 (aliskiren; Rasilez) | Oral renin inhibitor | Hypertension | Partner Novartis AG filed an NDA with the FDA, seeking approval in that indication (4/19) |
CENTRAL NERVOUS SYSTEM | ||||
Alkermes Inc. | Vivitrol | Long-acting, injectable form of naltrexone | Alcohol dependence | The FDA approved the once- monthly product; Cephalon Inc. has primary marketing and sales responsibility(4/13) |
Avanir | Neurodex | Oral combination of dextromethorphan and an enzyme inhibitor, quinidine | Pseudobulbar affect | The FDA accepted NDA filing and granted it priority review; action is expected by July 30 (4/4) |
Cephalon | Sparlon | New formulation and dosage of modafinil, the active ingredient in the approved product Provigil | Attention deficit hyperactivity disorder | The FDA extended its review period to Aug. 22, following the company's submission of new safety data (4/24) |
Cortex | CX717 | Ampakine analogue; designed to improve brain cell signaling | Attention deficit hyperactivity disorder | The FDA placed CX717 trials on hold due to concerns over pre-clinical animal data (4/3) |
Noven | Daytrana | Transdermal patch containing methylphenidate | Attention deficit hyperactivity disorder | The FDA approved the drug for treating ADHD in 6- to 12-year- olds; Shire plc will market the product (4/6) |
TheraQuest | Tramadol ER (TQ-1017) | Extended-release, abuse- deterrent formulation of tramadol | HIV-associated neuropathy | The FDA granted fast-track desig- nation to the product in that indication, for which a Phase I trial has been completed (4/18) |
INFECTION | ||||
Acambis plc | ACAM2000 | Second-generation vaccine derived from the Dryvax smallpox vaccine | Smallpox infection | Completed submission of BLA with FDA; the rolling submission began in January (4/18) |
Accentia Bio- | SinuNase | Intranasal amphotericin B formulation | Chronic sinusitis | The FDA granted fast-track status in that indication, for which Phase III trials were being planned (4/12) |
Gilead Sciences | -- | Once-daily tablet combining the anti-HIV drugs Sustiva and Truvada | HIV | Submitted NDA seeking approval of the product; Gilead's Truvada is a fixed-dose product containing Viread and Emtriva (4/27) |
| MISCELLANEOUS | ||||
BioSante | Bio-E-Gel | Estradiol transdermal gel | Hot flashes | NDA filed with FDA in February was accepted for review (4/19) |
Discovery | Surfaxin | Engineered version of natural human lung surfactant | Respiratory distress syndrome in premature infants | The FDA issued a second approvable letter; it asks for additional information on drug specifications (4/5); company said a manufacturing issue could lead to a potentially significant delay in the approval process (4/24) |
Edison | EPI-A0001 | Agent believed to target electron shuttling and energy production | Respiratory chain diseases | The FDA granted orphan designation to the agent for treating inherited mitochondrial respiratory chain diseases (4/4) |
Genzyme | Myozyme | Recombinant human acid alpha-lucosidase enzyme | Pompe disease | The FDA granted approval to the product in that indication; it marks the first treatment ever approved for the disease (4/28) |
Neurochem | Fibrillex | Glycosaminoglycan mimetic with anti- amyloid properties | Amyloid A amyloidosis | NDA filing completed in February was granted priority review; the PDUFA date is Aug. 13 (4/18) |
TopoTarget A/S (Denmark; | Totect (Savene) | Dexrazoxane; inhibitor of topoisomerase II | Antidote to anthracyline extravasation | The FDA accepted for review the NDA filing and granted it priority review status (4/12) |
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; NYSE = New York Stock Exchange; SWX = Swiss Stock Exchange. | ||||