FDA Submissions, Approvals And Other Actions: May 2005
Company* | Product | Description | Indication | Status |
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AUTOIMMUNE | ||||
Acorda | Fampridine-SR | Selective neuronal potassium channel blocker | Multiple sclerosis | Reached agreement with FDA on SPA for Phase III trial that will measure improvement in walking (5/4) |
Centocor Inc. | Remicade (FDA-approved) | Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha | Ulcerative colitis | Supplemental BLA filed with the FDA has been designated for priority review (5/31) |
Centocor Inc. | Remicade (FDA-approved) | Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha | Psoriatic arthritis | The FDA approved the drug to reduce the signs and symptoms of active arthritis in patients with PA; it is the ninth FDA approval of the product (5/17) |
La Jolla | Riquent | Abetimus sodium; B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA | Lupus | The FDA designated fast-track status to Riquent for treating lupus renal disease (5/31) |
CANCER | ||||
Amgen | Aranesp (FDA-approved) | Darbepoetin alfa, a recombinant erythropoietic protein | Anemia | Submitted supplemental NDA seeking approval of extended dosing to treat chemotherapy-induced anemia in patients with non-myeloid malignancies (5/6) |
Cell | GVAX | Whole-cell vaccine comprised of tumor cells irradiated and modified to secrete GM-CSF | Prostate cancer | Agreed to SPA with FDA for its second Phase III trial (VITAL-2) in prostate cancer; it will compare GVAX and Taxotere to Taxotere and prednisone (5/18) |
Lorus | GTI-2040 | Antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase | Acute myeloid leukemia | The FDA awarded orphan status to the drug in that indication, for which Phase II trials are ongoing (5/4) |
Onyx | Sorafenib (BAY 43-9006) | RAF kinase and VEGF inhibitor | Metastatic kidney cancer | The product was accepted into the FDA's Pilot 1 Program for continuous marketing applications (5/4) |
OSI | Tarceva (FDA-approved) | Erlotinib HCl; small- molecule HER1/EGFR inhibitor | Advanced pancreatic cancer | Submitted supplemental NDA for use of drug with gemcitabine for treating advanced, previously untreated patients (5/2) |
Structural | Troxatyl | Troxacitabine; nucleoside analogue | Acute myelogenous leukemia | The FDA granted orphan designation to the drug, which is in Phase I/II trials in that indication (5/12) |
CARDIOVASCULAR | ||||
Arginox | Tilarginine Acetate Injection | Agent designed to inhibit the production of nitric oxide | Cardiogenic shock | The FDA granted orphan designation to the product in that indication, for which Phase III trials were starting (5/23) |
Encysive | Thelin | Sitaxsentan; small molecule designed to block endothelin | Pulmonary arterial hypertension | Filed NDA with FDA seeking approval as a once-daily treatment for patients with PAH (5/25) |
PR | PulmoLAR | 2-methoxyestradiol (2ME), an endogenous non- estrogenic metabolite of estradiol | Pulmonary arterial hypertension | The FDA granted orphan designation to the drug; Phase I trials are expected to begin in 2005 (5/12) |
CENTRAL NERVOUS SYSTEM | ||||
Alkermes Inc. | Vivitrex | Long-acting, injectable form of naltrexone | Alcohol dependence | The FDA granted priority review to the NDA, which was filed in May, putting the review deadline at Sept. 30, 2005 (5/27) |
Alkermes Inc. | Risperdal Consta (FDA-approved) | Risperidone formulated in Alkermes' long-acting Medisorb technology | Psychosis of Alzheimer's disease | The FDA issued J&J a not-approvable letter on the supplemental NDA filing (5/26) |
CytRx Corp. | Arimoclomol | Small molecule designed to provide cellular protection by activating molecular chaperone proteins | Amyotrophic lateral sclerosis | The FDA granted orphan drug designation to the product in ALS (5/5) |
Neurocrine | Indiplon | Tablet form of a non-benzodiazepine agent that targets the GABA-A receptor | Insomnia | The company has completed submission of an NDA with the FDA for treating insomnia in both adult and elderly patients (5/26) |
INFECTION | ||||
Depomed Inc. | Proquin XR | Once-daily, extended- release formulation of ciprofloxacin hydrochloride | Uncomplicated urinary tract infections | The FDA approved the product; Depomed was in late- stage negotiations with potential marketing partners (5/20) |
Vicuron | Anidulafungin | Broad-spectrum agent from the echinocandin class | Esophageal candidiasis | Filed amendment to existing NDA; amendment in invasive candidiasis/candidemia is expected in the third quarter (5/31) |
Vicuron | Dalbavancin | Glycopeptide agent from the same class as vancomycin | Complicated skin and soft-tissue infections | The FDA said it would extend its review date on the NDA for three months; action now is expected by Sept. 21, 2005 (5/11) |
MISCELLANEOUS | ||||
Copernicus | -- | Drug based on DNA nanoparticle technology | Cystic fibrosis | The FDA granted orphan desig-nation to the drug in that indication (5/2) |
Halozyme | Hylenex (formerly Enhanze SC) | Formulation of recombinant human hyaluronidase | For use as a spreading agent | The FDA accepted the NDA for filing and review; it was filed in March (5/26) |
InKine | INKP-102 | New-generation sodium phosphate purgative tablet | Bowel cleansing prior to colonoscopy | The company filed an NDA seeking approval of the product (5/3) |
Tercica Inc. | Increlex | Mecasermin injection; recombinant human insulin-like growth factor-1 | Short stature caused by IGF deficiency | The FDA accepted for filing and granted priority review to the NDA, which was filed in February (5/2) |
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Notes: | ||||
* Privately held. | ||||
BLA = Biologics license 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. | ||||
AMEX = American Stock Exchange; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange. | ||||