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T-20, Fusion Inhibitor and its Availability
Press Release from Roche and Trimeris
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Roche and Trimeris, Inc. today announced that the U.S. Food and Drug
Administration (FDA) has notified the companies that the New Drug
Application (NDA) for FUZEON(TM) (generic: enfuvirtide, formerly known
as T-20) is fileable and has been granted priority review status. Designed
for the treatment of HIV-1 in combination with other antiretroviral agents,
FUZEON is the most clinically advanced in an investigational class of anti-
HIV drugs called "fusion inhibitors."
The priority review designation establishes a target six-month review
period for the FUZEON NDA, which was submitted by Roche and Trimeris on
September 16, 2002. The FDA will, therefore, take an action on the NDA
by March 16, 2003 (the user fee action date). According to FDA policies
and procedures, priority designation is granted to medications that, if
approved, address unmet medical needs, offering a significant improvement
in the safety or effectiveness of the treatment, diagnosis or prevention
of a serious or life-threatening disease.
Unlike existing anti-HIV drugs that work inside the cell, FUZEON has a
unique mechanism of action and is designed to block HIV before it enters
the human immune cell. Consequently, FUZEON is active against HIV that
is resistant to the currently available classes of anti-HIV drugs.
"The NDA submission for FUZEON was based on 24-week results of innovative
and rigorous Phase III clinical trials in treatment-experienced patients.
The granting of priority review status by the FDA is a critical milestone
in bringing FUZEON to patients," said Georges Gemayel, Vice President
Specialty Care, Roche.
"If approved, FUZEON will represent a significant advance in the treatment
of HIV," said Dr. Dani Bolognesi, Chief Executive Officer, Trimeris. "Due
to drug resistance and tolerability issues, the population of treatment -
experienced patients in need of new therapies continues to grow. FUZEON
has the potential to help address this unmet need."
Phase III 24-Week Results
The filing submission for FUZEON was based on 24-week data from two large,
international Phase III trials, TORO 1 and TORO 2 (TORO: "T-20 vs. Optimized
Regimen Only." In the TORO studies, combination therapy with FUZEON reduced
HIV to undetectable levels in the blood in at least twice the percentage of
patients and provided an improved immune response at 24 weeks, as compared
to those who took combination therapy without FUZEON. FUZEON also provided a
significant increase in CD4+ immune cells at 24 weeks.
Additional analyses of TORO 1 24-week data showed that the response of
patients taking FUZEON plus an individualized background regimen surpassed
that of patients on the individualized regimen alone regardless of patient
demographics or treatment history.
More About FUZEON
FUZEON, a fusion inhibitor, is a self-administered twice-daily subcutaneous
injection. Local injection site reactions were the most frequent adverse
events associated with the use of FUZEON. In Phase III clinical studies,
98 percent of patients had at least one local injection site reaction;
however, these reactions were seldom treatment limiting, with only three
percent of patients discontinuing treatment with FUZEON.
The addition of FUZEON to background antiretroviral therapy generally
did not increase the frequency or the severity of the majority of adverse
events. The absolute difference in the most common adverse events seen
between FUZEON plus an individualized background regimen of antiretroviral
drugs and individualized background regimen alone was less than five
percent. The events most frequently reported in patients receiving FUZEON
plus an
individualized background regimen and higher in patients receiving FUZEON
than in patients who received treatment without FUZEON were, headache,
peripheral neuropathy, dizziness (excluding vertigo), insomnia, depression,
appetite decrease, asthenia, myalgia, constipation and pancreatitis.
The majority of adverse events were of mild or moderate intensity.
Access to FUZEON
As increasing numbers of patients with HIV are in need of new therapies,
it is possible that demand for FUZEON may exceed supply at the projected
time of launch in 2003. Roche and Trimeris fully appreciate the compelling
need for FUZEON and are working diligently to bring FUZEON to patients with
the greatest medical need as early as possible and in the greatest number
possible, but also in a manner to ensure continuity of supply. Considerable
investment has already been made and will be further committed to increase
capacity for FUZEON production to accommodate the potentially increasing
demand for this important medication.
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