FDA Submissions, Approvals And Other Actions: April 2000
Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER | ||||
Aphton Corp. (APHT) | | Anti-gastrin therapeutic vaccine; neutralizes hormone G17 and Gly-extended G17 | Metastatic pancreatic cancer | Received FDA clearance of Phase III trial of combination therapy with gemictabine vs. gemcitabine alone (4/11) |
BioTime Inc. (AMEX:BTX) | PentaLyte | Pentastarch-based physiologically balanced blood plasma volume expander | Replacement of blood volume in a variety of surgical applications | FDA cleared Phase I trial (4/18) |
Matrix Pharmaceutical Inc. (MATX) | IntraDose | Biodegradable gel containing cisplatin and epineephrine (intra-tumoral injection) | Squamous cell carcinoma | Submitted initial section of NDA (4/3); orphan drug status granted (4/13) |
Neurocrine Biosciences Inc. (NBIX) | NBI-3001 | Interleukin-4 Pseudomonas toxin fusion protein; chimeric protein linking inter-leukin-4 (which binds to cancer cells because they express elevated levels of the IL-4 receptor) and Pseudomonas exotoxin (a cytotoxin) | Astrocytic glioma | Granted orphan drug status (4/27) |
CENTRAL NERVOUS SYSTEM | ||||
Atlantic Technology Ventures (ATLC) | CT-3 | Ajulemic acid; synthetic derivative of trahydrocan-nabinol (THC-11-oic acid) | Pain relief | Filed IND (4/3) |
Novartis Pharmaceuticals Corp. (unit of Novartis AG; Switzerland) | Exelon capsules | Rivastigmine tartrate; cholinesterase inhibitor | Mild to moderate Alzheimer's disease | Cleared for marketing (4/24) |
INFECTION | ||||
OraPharma Inc. (OPHM) | MPTS | Minocycline periodontal therapeutic system; microsphere encapsulated formulation of the antibiotic minocycline | Periodontitis | NDA accepted for review (4/26) |
Triangle Pharmaceuticals Inc. (VIRS) | Coviracil | Emtricitabine; antiviral nucleoside analogue | HIV infection | FDA issued clinical hold on FTC-302 trial, which is being conducted in South Africa under a U.S. IND; NDA may be delayed until at least 2H:00 (4/7) |
Xoma Ltd. (XOMA) and Baxter Healthcare Corp. (NYSE:BAX) | Neuprex | Recombinant bactericidal/permeability increasing protein (rBPI-21) | Severe meningo-coccemia in children | FDA officials said Phase III trial results were insufficient to support BLA filing; companies are looking for additional ways to supply the data (4/25) |
MISCELLANEOUS | ||||
Alexion Pharmaceuticals Inc. (ALXN) | 5G1.1 | Monoclonal antibody complement inhibitor | Pemphigoid | Filed IND (4/6) |
Atrix Laboratories Inc. (ATRX) | Dapsone topical gel | Topical formulation of dapsone, an antibiotic and anti-inflammatory agent burn wounds | Chronic itch associated with healed and healing | Submitted IND (4/27) |
Coherent Inc. (COHR) | Opal Photo-activator | Laser for use in conjunction with Visudyne, QLT's photodynamic therapy (see separate entry below) | Wet form of age-related macular degeneration | Cleared for marketing (4/13) |
Gliatech Inc. (GLIA) | Adcon-P | Adhesion control barrier; resorbable carbohydrate polymer liquid | Prevention of post-surgical scarring following gynecological pelvic surgery | FDA agreed to review product under PMA modular review process and accepted first module (4/6); FDA accepted second module (4/20) |
Immunex Corp. (IMNX) | Enbrel (FDA-approved) | Etanercept; recombinant, soluble T75 tumor necrosis factor receptor (TNFr) linked to the Fc portion of human IgG1 | Delay of radiographic progression of joint damage in patients with early rheumatoid arthritis | Arthritis Advisory Committee unanimously recommended approval of additional indication (4/11) |
Organogenesis Inc. (AMEX:ORG) | Apligraf | Living human skin equivalent, composed of living human keratinocytes and fibroblasts | Diabetic foot ulcers | PMA to be reviewed by the General and Plastic Surgery Devices Panel 5/8/00 (4/7) |
QLT PhotoTherapeutics Inc. (Canada;QLTI) | Visudyne | Verteporfin for injection; photodynamic therapy is activated through use of specially designed laser that produces low-level, non-thermal 689 nm light | Wet form of age-related macular degeneration | Cleared for marketing (4/13) |
Repligen Corp. (RGEN) and ChiRhoClin Inc.* | Secretin-Repligen | Synthetic porcine secretin | Pancreatic function diagnostic | Received approvable letter (4/28) |
Zonagen Inc. (ZONA) | Vasomax and Vasofem | Phentolamine mesylate-based products | Erectile dysfunction (Vasomax) and female sexual arousal disorder (Vasofem) | Submitted final results of two-year rat study required by FDA to lift clinical hold (4/18) |
Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; CDNX = Canadian Venture Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange | ||||
BLA = Biologics license application | ||||
IND = Investigational new drug application | ||||
NDA = New drug application | ||||
ND = Not disclosed | ||||
PMA = Premarket approval application | ||||