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Roche and Trimeris Announce FDA Filing of FUZEON
sNDA for Administration with a Needle-Free Injection Device
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New Study of FUZEON with Biojector 2000 to Begin in August 2005 – There will be a study presented about this devise & T20 at the Intl AIDS Society conference in Rio next week.
Nutley, N.J. and Morrisville, N.C. (July 18, 2005) – Roche and Trimeris (Nasdaq: TRMS) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of their sNDA to consider inclusion of information about the Biojector 2000 (B2000) needle-free injection device in the FUZEON (enfuvirtide) labeling. The filing is based on data from the T20-405 study, a single-dose, comparative pharmacokinetic study of FUZEON administered via the needle-free device compared to standard needle-syringe administration. Results from this study were presented at the HIV DART meeting in December 2004. FUZEON is the first and only entry inhibitor available for the treatment of HIV; it is approved for use with a needle and syringe.
The companies anticipate that the FDA will provide feedback and a decision on the sNDA later this year. In a related development, Trimeris and Roche plan to begin enrollment of a new trial – the FUZEON WAND (FUZEON With A Needle-free Device) study, assessing patient acceptance and experience in administration of FUZEON via the B2000 needle-free device compared to standard needle and syringe administration. Anticipated to start in August 2005, this study will enroll 40 patients, in a month-long, cross-over design evaluation. Endpoints include tolerability, injection site reactions and pharmacokinetics.
The B2000 injection system, manufactured by Bioject Medical Technologies Inc., is a needlefree CO2-powered injector that disperses liquid medication through the skin. The B2000 has been available since 1996 to deliver subcutaneous and intramuscular injections and has been used in vaccine delivery, chronic therapy and other settings, delivering millions of injections worldwide (for more information, please refer to www.bioject.com or 800.683.7221).
For more information on FUZEON, patients and physicians can visit www.FUZEON.com or call 1-877-4FUZEON.
Facts About FUZEON
FUZEON is the first and only fusion inhibitor for the treatment of HIV. Unlike other HIV drugs that work after HIV has entered the human immune cell, FUZEON works outside the CD4 cell, blocking HIV from entering the cell. For this reason, FUZEON is effective in treatment-experienced patients who have developed resistance to other anti-HIV drugs, though patients may still develop resistance to FUZEON. FUZEON was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in March 2003 on the basis of 24-week data, and was granted traditional (full) approval on Oct. 15, 2004 on the basis of long-term 48-week data.
Injection Site Reactions (ISRs): ISRs are the most common adverse events associated with FUZEON. ISRs occurred in 98% of patients studied and 4% discontinued FUZEON due to ISRs. Signs/symptoms may include pain and discomfort, hardened skin, redness, bumps, itching and swelling. Eleven percent of patients had local reactions that required analgesics or limited usual activities.
Pneumonia: An increased rate of bacterial pneumonia was observed in subjects treated with FUZEON in the Phase III clinical trials compared to the control arm. It is unclear if the increased incidence of pneumonia is related to FUZEON use. Patients with HIV infection should be carefully monitored for signs and symptoms of pneumonia. Risk factors for pneumonia included low initial CD4 cell count, high initial viral load, intravenous drug use, smoking and a prior history of lung disease.
Hypersensitivity Reactions: Systemic hypersensitivity reactions have been associated with FUZEON therapy and may recur on rechallenge. Hypersensitivity reactions have included individually and in combination: rash, fever, nausea and vomiting, chills, rigors, hypotension and elevated serum liver transaminases. Other adverse events that may be immune mediated and have been reported in subjects receiving FUZEON include primary immune complex reaction, respiratory distress, glomerulonephritis and Guillain-Barre syndrome.
Other Adverse Events: The events most frequently reported in patients receiving FUZEON plus an optimized background regimen were diarrhea (32%), nausea (23%) and fatigue (20%). These events were seen at a lower incidence in patients taking a FUZEON-based regimen compared to those receiving an optimized background regimen without FUZEON when taking into account the uneven number of patients in each arm and the length of time they are in that arm. As measured in number per 100 patient-years, the incidence was: diarrhea (38 per 100 patient-years in subjects receiving FUZEON-based regimens vs. 73 per 100 patient-years in patients who did not receive FUZEON),
nausea (27 vs. 50, respectively) and fatigue (24 vs. 38, respectively).
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