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FDA Grants Full traditional Approval for Fuzeon
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Roche released this announcement on Friday Oct 15
U.S. FDA Grants Traditional Approval for FUZEON, First and Only Fusion Inhibitor for the Treatment of HIV
-- Designation Follows March 2003 Accelerated Approvaland Further Confirms Safety and Efficacy at 48 Weeks --
NUTLEY, N.J. and DURHAM, N.C. (Oct. 15, 2004) -- Roche and Trimeris, Inc. (Nasdaq: TRMS) today announced that the U.S. Food and Drug Administration (FDA) has granted traditional approval to FUZEON (enfuvirtide), the first and only fusion inhibitor for the treatment of HIV. The FDA granted accelerated approval to FUZEON on the basis of 24-week data in March 2003; accelerated approval is a special regulatory status designed to expedite the approval of therapies for serious or life-threatening illnesses which provide meaningful benefit to patients over existing treatments. The traditional approval of FUZEON was based on results from Phase III clinical trials over 48 weeks which confirmed the durable efficacy and safety of FUZEON-based regimens.
"The 48-week data confirm that enfuvirtide-based regimens substantially improve virologic and immunologic outcomes in treatment experienced patients after approximately one year of therapy. Forty-six percent of patients on enfuvirtide-based regimens achieved a significant reduction in HIV levels, compared to 18 percent of patients taking previous standard of care regimens.1 These strong results establish enfuvirtide as an invaluable component of therapy for triple-class experienced patients who require a change in regimen," said Joel Gallant, M.D., M.P.H., Associate Professor of Medicine and Epidemiology, Division of Infectious Diseases, The Johns Hopkins University School of Medicine, Baltimore, Maryland.
"The traditional approval of FUZEON further confirms its importance as a crucial option for treatment-experienced HIV patients," said Steven D. Skolsky, CEO, Trimeris. "Together with our partner Roche, Trimeris is proud to reach this important milestone for FUZEON. The significance of this milestone is further reinforced by data recently presented at the XV International AIDS Conference (IAC), which show that FUZEON is not only potent, but durable over 96 weeks."
FUZEON in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. This indication is based on results from two controlled studies of 48 weeks duration. Subjects enrolled were treatment-experienced adults; many had advanced disease. There are no studies of FUZEON in antiretroviral naïve patients. Injection site reactions are the most common adverse event associated with FUZEON use. Other common side effects occurring in patients taking FUZEON are diarrhea (32%), nausea (23%), and fatigue (20%). A safety analysis at 48 weeks showed that the incidence of these three common side effects was less frequent in patients taking FUZEON-based regimens compared to those who did not receive FUZEON. (See "Facts About FUZEON" section for complete safety information.)
FUZEON Receives International Recognition for Innovation
This FUZEON approval milestone reflects a long history of Roche innovation in the field of HIV. Most recently, FUZEON has received the 2004 International Prix Galien award for the most innovative new medicine. The award recognizes significant advances in pharmaceutical research, identifying the most important drugs introduced into the market and the most significant research team in the pharmaceutical field. FUZEON was selected out of 12 major new drugs from all therapeutic areas, each of which had won national awards throughout Europe.
The very first International Prix Galien award was granted in 1998 to Invirase (saquinavir), Roche's HIV protease inhibitor, and Roche is the first company to be honored with this prestigious awarded twice in the field of HIV.
"This distinguished award is another testament to Roche's commitment to innovation and development of truly novel medicines. It brings great pride and motivation to everyone at Roche," said George B. Abercrombie, president and CEO, Hoffmann-La Roche.
Facts About FUZEON
FUZEON, co-developed by Roche and Trimeris (Nasdaq: TRMS) is also approved in the European Union, Switzerland and Canada. 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.
TORO Study Design
TORO 1 [T-20 (FUZEON) vs. Optimized Regimen Only] and TORO 2 were randomized, openlabel trials that enrolled approximately 1,000 HIV-1 infected patients at 112 centers internationally. Patients were treatment-experienced and/or had documented resistance to each of the other three classes of anti-HIV drugs. At entry, resistance testing and patient treatment history were used together to aid in the selection of an individualized regimen of three to five anti-HIV drugs for each patient. After selection of the regimen, patients were randomized 2:1 to receive either the regimen in combination with FUZEON (FUZEON arm) or the individualized regimen alone (control arm). At baseline, patients had a median HIV RNA level of more than 5.0 log10 copies/mL, a median CD4 cell count of less than 100 cells/mm3, and had been treated with anti-HIV drugs for an average of seven years.
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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