FDA Submissions, Approvals And Other Actions: August 2005
Company* | Product | Description | Indication | Status |
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AUTOIMMUNE | ||||
Genentech | Rituxan | Rituximab; antibody that targets and selectively depletes CD20- positive B cells | Rheumatoid arthritis | Filed supplemental BLA seeking approval in patients with active RA who inadequately respond to an anti-TNF therapy (8/31) |
CANCER | ||||
Amgen Inc. | Panitumumab | Fully human monoclonal antibody directed against the epidermal growth factor receptor | Metastatic colorectal cancer | The FDA granted fast-track designation to the product; a BLA filing is planned before the end of 2005 (8/1) |
AmpliMed | Amplimexon | Imexon injection; a cyanoaziridine compound believed to disrupt mitochondria | Ovarian cancer | The FDA granted orphan designation to the product in that indication; it already had orphan status in three other cancer indications (8/30) |
Antisoma plc | AS1411 | Anti-nucleolin aptamer | Renal cancer | The FDA granted orphan designation to the Phase I product in that indication (8/17) |
Ariad | AP23573 | Oral form of agent designed to inhibit cell-signaling protein mTOR | Soft-tissue and bone sarcomas | The FDA granted orphan designation to the drug in both indications (8/18) |
Genentech | Rituxan (FDA-approved) | Rituximab; antibody that targets and selectively depletes CD20-positive B cells | Non-Hodgkin's lymphoma | Filed supplemental NDA seeking approval in previously untreated patients with intermediate-grade or aggressive, CD20-positive, B- cell NHL, in combination with other chemotherapy regimens (8/17) |
ImClone | Erbitux (FDA-approved) | Cetuximab; antibody that blocks the epidermal growth factor receptor | Head and neck cancer | Filed supplemental BLA seeking approval for use with radiaiton in advanced squamous cell carcinoma of the head and neck and as a monotherapy in platinum-based failures (8/30) |
CARDIOVASCULAR | ||||
CoTherix Inc. | Ventavis (FDA-approved) | Inhaled formulation of iloprost, a prostacyclin analogue | Pulmonary arterial hypertension | The FDA expanded the drug's label to include use with Tracleer and for use with the hand-held I-neb AAD device (8/30) |
CENTRAL NERVOUS SYSTEM | ||||
Cognetix Inc.* | CGX-1160 | Broad-spectrum non-opioid analgesic based on peptide synthesized from marine cone snails | Neuropathic pain | The FDA granted orphan status to the Phase Ib product for the intrathecal treatment of neuropathic pain associated with spinal cord injury (8/30) |
CytRx Corp. | Arimoclomol | Small molecule designed to provide cellular protection by activating molecular chaperone proteins | Amyotrophic lateral sclerosis | The FDA requested additional information in order to release a clinical hold it placed on planned Phase II trials (8/10) |
Pozen Inc. (POZN) | Trexima (MT400) | Single-tablet combination of sumatriptan (5-T1B/1D agonist) and naproxen | Migraine | Pozen filed an NDA with the FDA seeking approval of the agent (8/8) |
Pozen Inc. | MT 100 | Metoclopramide hydro- chloride combined with naproxen sodium | Migraine | FDA advisory panel voted that potential risk for tardive dyskinesia would outweigh benefits; the FDA issued a not-approvable letter in June 2004; Pozen ended development of the drug (8/5) |
TheraQuest | TQ-1017 | Abuse-deterrent, once-daily, extended-release tramadol | Postherpetic neuralgia | The FDA granted orphan designation to the product in that indication (8/11) |
INFECTION | ||||
Arpida Ltd. | Iclaprim | Capsule formulation of broad- spectrum antibiotic infections | Complicated skin and skin- structure | The FDA granted fast-track status to the product in that indication (8/23) |
Chiron Corp. | Fluvirin (FDA-approved) | Influenza vaccine | Influenza | The FDA OK'd Chiron's manufacturing facility in the UK, allowing the company to provide the vaccine for the 2005-06 flu season (8/31) |
Vicuron | Anidulafungin | Broad-spectrum agent from the echinocandin class | Invasive candidiasis/candidemia | Filed NDA with the FDA seeking approval in that indication (8/18) |
MISCELLANEOUS | ||||
BioMarin | Orapred ODT | Prednisolone sodium phosphate tablets; new formulation of Orapred | Inflammation reduction | Submitted an NDA with the FDA (8/1) |
CollaGenex | Oracea | Non-antimicrobial tetracycline derivative | Rosacea | Filed NDA with the FDA seeking approval in that indication (8/1) |
Discovery | Surfaxin | Engineered version of natural human lung surfactant | Respiratory distress syndrome in premature infants | The FDA said Discovery needed to provide more information in its response letter to the approvable letter received in February (8/15); the questions center on chemistry and manufacturing (8/19) |
Tercica Inc. | Increlex | Mecasermin injection; recombinant human insulin-like growth factor-1 | Short stature caused by IGF deficiency | The FDA approved the drug for long-term treatment of growth failure in children with severe primary IGF-1 deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone (8/31) |
Large Scale | -- | Recombinant human lysosomal acid lipase | Various diseases | The FDA granted orphan designation to the product, which is targeted toward the metabolism of certain lipids (8/1) |
Neurochem | Fibrillex | Glycosaminoglycan mimetic with anti-amyloid properties | Amyloid A amyloidosis | Initiated rolling NDA submission with the FDA; complete filing is expected around year-end (8/22) |
Unigene | Fortical | A nasal calcitonin product | Osteoporosis | The FDA approved the product for treating postmenopausal osteoporosis; Upsher-Smith Laboratories Inc. will market it (8/15) |
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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. | ||||
LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange. | ||||