FDA Submissions, Approvals And Other Actions: June 2005
Company* | Product | Description | Indication | Status |
AUTOIMMUNE | ||||
Amgen Inc. | Enbrel (FDA-approved) | Etanercept; anti-tumor necrosis factor-alpha antibody | Psoriatic arthritis | The FDA approved an expanded indication, to improve physical function in PA patients; it was approved for treating PA in 2002 (6/1) |
Genelabs | Prestara | Prasterone; synthetic equivalent of dehydro- epiandrosterone | Lupus | The FDA said that preventing loss of bone mineral density in patients on glucocorticoids qualifies for orphan exclusivity under the original orphan designation (6/22) |
CANCER | ||||
BioCryst | Fodosine | Transition-state analogue inhibitor of the enzyme purine nucleoside phosphorylase | Relapsed/ refractory T-cell leukemia | The FDA granted fast-track status to the drug in that indication, for which Phase IIa trials are ongoing (6/20) |
Callisto | Annamycin | Second-generation anthracycline | Acute lypho- blastomic leukemia and acute myeloid leukemia | The FDA granted orphan designation to the product in ALL (6/24); the product also gained orphan designation in AML (6/28) |
Celgene Corp. | Revlimid | Lenalidomide; derivative of Thalomid (thalidomide) | Myelodysplastic syndromes | The FDA accepted for review the NDA seeking approval for transfusion-dependent MDS patients with deletion 5q chromosomal abnormality (6/7); the NDA was granted priority review (6/21) |
Genta Inc. | Genasense | Oblimersen sodium; inhibits function of bcl-2 protein | Relapsed/ refractory chronic lymphocytic leukemia | Initiated submission of NDA seeking approval for use in combination with fludarabine plus cyclophosphamide (6/30) |
Lorus | Virulizin | Immunotherapy agent designed to stimulate the immune system | Pancreatic cancer | The FDA accepted Lorus' plan on a rolling NDA submission (6/13) |
CARDIOVASCULAR | ||||
DiaDexus | PLAC | Blood test that measures lipoprotein-associated phospholipase A2 test | Ischemic stroke | The FDA approved the test to aid in predicting risk for ischemic stroke associated with athero-sclerosis (6/17) |
NitroMed Inc. | BiDil | Nitric oxide-enhancing oral agent; combination of isosorbide dinitrate and hydralazine | Heart failure in African-Americans | FDA panel voted 9-0 in recommending approval of the drug (6/15); the FDAapproved the drug (6/23) |
Penwest | PW2101 | Low-dose formulation of a beta blocker | Hypertension and angina | The FDA issued a non-approvable letter on the NDA, partly due to kinetic variability and beta blockade as a surrogate for efficacy was not demonstrated; Penwest is dropping the compound (6/29) |
The Medicines | Angiomax (FDA-approved) | Bivalirudin; direct thrombin inhibitor | Anticoagulant | The FDA expanded the label to include patients undergoing percutaneous coronary intervention (6/15) |
CENTRAL NERVOUS SYSTEM | ||||
Avanir | Neurodex | Oral combination of dextromethorphan and an enzyme inhibitor, quinidine | Pseudobulbar affect | The company submitted the final modules of its rolling NDA filing (6/30) |
Neurocrine | Indiplon | Capsule form of a non- benzodiazepine agent that targets the GABA-A receptor | Insomnia | The FDA accepted for review the company's resubmitted NDA (6/14) |
DIABETES | ||||
Depomed Inc. | Glumetza | Once-daily, extended-release formulation of metformin hydrochloride | Type II diabetes | The FDA approved the product; Biovail, which has U.S. rights, is seeking a marketing partner (6/3) |
INFECTION | ||||
Advancis Pharmaceutical Corp. (AVNC) | Amoxicillin Pulsys | Amoxicillin formulation delivered with once-daily pulsatile Pulsys technology | Strep throat | Phase III trial in patients with pharyngitis/tonsillitis due to Group A streptococcal infections failed to achieve microbiological and clinical endpoints (6/15) |
Vical Inc. | -- | Bivalent formulation of the company's vaccine against cytomegalovirus | CMV viremia | The FDA designated the vaccine an orphan drug; it is nearing Phase II trials in hematopoietic cell transplant recipients (6/14) |
MISCELLANEOUS | ||||
BioMarin | Naglazyme | Galsulfase; an enzyme- replacement therapy | Mucopoly- saccharidosis-VI | The FDA approved the drug, which has orphan status in the U.S. (6/1) |
Chiron Corp. | Pulminiq | Cyclosporine inhalation solution | For use in patients getting lung transplants | An FDA advisory panel split 8-8 on whether the drug provides a survival benefit (6/6) |
Insmed Inc. | SomatoKine | Composition of insulin- like growth factor-1 and its primary binding protein BP3 | Growth hormone insensitivity syndrome | The FDA extended the user-fee date on the NDA three months to Oct. 3, 2005, to give it time to review response data (6/10) |
Inspire | Diquafosol tetrasodium | Ophthalmic solution; P2Y2 receptor agonist | Dry-eye disease | Submitted amendment to an NDA filed in 2003; the filing includes data from two additional Phase III trials (6/1) |
Neurochem | Fibrillex | Glycosaminoglycan mimetic with anti- amyloid properties | Amyloid A amyloidosis | Neurochem intends to provide additional follow-up data from an open-label extension trial after the FDA said it would review an NDA based on Phase II/III data (6/30) |
Santarus Inc. | Zegerid | Immediate-release capsule formulation of the proton pump inhibitor omeprazole | Gastrointestinal disorders | The FDA accepted for filing the NDA, which is seeking approval for treating heartburn and symptoms of other conditions (6/28) |
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. | ||||
AMEX = American Stock Exchange; TSE = Toronto Stock Exchange. | ||||