FDA Submissions, Approvals And Other Actions: February 2005
Company* | Product | Description | Indication | Status |
CANCER | ||||
Rexahn Corp.* | RX-0201 | Signal inhibitor that blocks the protein kinase Akt | Advanced cancer | The FDA granted orphan designation to the drug in ovarian, renal-cell, stomach and pancreatic cancers, and glioblastoma (2/1) |
Vical Inc. | Allovectin-7 | DNA plasmid/lipid complex containing the DNA sequences encoding HLA-7 and ß2 microglobulin | Metastatic melanoma | Reached agreement with FDA on SPA for Phase III trial in 375 patients with recurrent disease (2/10) |
Vion | Cloretazine | Sulfonyl hydrazine DNA alkylating agent | Acute myelogenous leukemia | Reached agreement with FDA on SPA for a Phase III trial with Ara- in 420 patients in first relapse (2/10) |
Viventia | Proxinium | Antibody fragment conjugated with a cancer-killing payload | Head and neck cancer | The FDA granted orphan designation to the product for treating advanced, recurrent disease (2/3) |
Xcyte Therapies | Xcellerated T Cells | T cells from patient stimulated to carry out immune functions | Chronic lymphocytic leukemia trial | The FDA requested a withdrawal of a planned Phase II/III trial to allow additional discussion of the design (2/2) |
CARDIOVASCULAR | ||||
AtheroGenics | AGI-1067 | Oral agent designed to inhibit the production of VCAM-1 and other molecules in the inflammatory process | Atherosclerosis | The FDA OK'd company's plan to increase enrollment in Phase III ARISE trial, to 6,000 patients from 4,000 (2/22) |
Inotek Pharmaceuticals Corp.* | INO-1001 | Inhibitor of the nuclear cell death enzyme poly (ADP-ibose) polymerase | Aortic aneurysm repair | The FDA granted orphan designation to the drug for preventing post-operative complications of aortic aneurysm repair (2/15) |
NitroMed | BiDil | Nitric oxide-enhancing oral agent; combination of isosorbide dinitrate and hydralazine | Heart failure in African-Americans | The FDA accepted the resubmission of the NDA; the PDUFA date is June 23 (2/3) |
CENTRAL NERVOUS SYSTEM | ||||
StemCells | HuCNS-SC | Human neural stem cells | Batten disease | The FDA had questions and suggestions on the company's IND, putting the proposed Phase I trial on hold (2/1) |
TheraQuest | TQ-1017 | Abuse-deterrent, once-daily, extended-release formulation of tramadol | HIV-associated neuropathy | The FDA granted orphan designation to the product in that indication (2/17) |
INFECTION | ||||
Aerogen Inc. | -- | Aerosolized formulation of amikacin | Ventilator- associated pneumonia | The FDA granted fast-track designation to the product, which is in Phase II trials (2/22) |
DVC LLC | VIGIV | Intravenous vaccinia immune globulin | Side effects of smallpox vaccine | The FDA approved the orphan product for treating adverse reactions to smallpox vaccination (2/22) |
Vicuron | Dalbavancin | Glycopeptide agent from the same class as vancomycin | Complicated skin and soft-tissue infections | NDA for the drug filed in December was granted priority-review status by the FDA (2/24) |
MISCELLANEOUS | ||||
BioBalance Corp. | Probactrix | Strain of E. coli in a BioBalance formulation | Pouchitis | The FDA had questions about the IND, putting the proposed trial on hold (2/4) |
BioMarin | rhASB (Aryplase) | Galsulfase; an enzyme-replacement therapy | Mucopoly-saccharidosis-VI | The FDA accepted for filing and assigned six-month review to the BLA, which was filed in November (2/1) |
Discovery | Surfaxin | Engineered version of natural human lung surfactant | Respiratory distress syndrome in premature infants | The FDA had issues with the contract manufacturer of the product, setting back the review period; the NDA was filed in April 2004 (2/1); the FDA issued an approvable letter that did not call for additional trials, only resolution of manufacturing and labeling issues (2/14) |
Nastech | Nascobal | Nasally delivered formulation of cyanocobalamin | Vitamin B-12 deficiency | The FDA approved the product; Questcor Pharmaceuticals Inc. has worldwide marketing rights (2/1) |
Pharmaxis Inc. | Bronchitol | Mannitol formulation delivered via an inhalation device | Bronchiectasis | The FDA granted orphan designation to the product, which is in human trials in that indication (2/9) |
Tercica Inc. | Increlex | Mecasermin injection; recombinant human insulin-like growth factor-1 | Short stature caused by IGF deficiency | Filed NDA with FDA seeking approval for the long-term treatment of growth failure in children with a severe form of primary IGF-1 deficiency (2/28) |
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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. | ||||
ASX = Australian Stock Exchange; OTC BB = Over-the-Counter Bublletin Board; TSE = Toronto Stock Exchange. | ||||