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FDA Approves INTELENCE(TM) (etravirine) For HIV Combination Therapy
The U.S. Food and Drug
Administration (FDA) has granted accelerated approval to the anti-HIV
medication INTELENCE (etravirine) tablets -- the first non-nucleoside
reverse transcriptase inhibitor (NNRTI) to show antiviral activity in
treatment- experienced adult patients with HIV resistant to a NNRTI and
other antiretroviral (ARV) agents. INTELENCE, also known as TMC125, was
developed by Tibotec Pharmaceuticals, Ltd. and will be marketed in the U.S.
by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.
"NNRTIs have been used in HIV combination therapy for more than a
decade, but their use has been limited by cross-resistance within the
class. Resistance to one NNRTI generally meant resistance to all NNRTIs,"
said Richard Haubrich, M.D., Professor of Medicine, Division of Infectious
Diseases, University of California, San Diego, and investigator in the
INTELENCE Phase 3 DUET studies. "Etravirine breaks new ground in the NNRTI
class, and provides a new option to thousands of treatment-experienced
patients with NNRTI-resistant HIV."
INTELENCE, in combination with other antiretroviral agents, is
indicated for the treatment of human immunodeficiency virus type 1 (HIV-1)
infection in antiretroviral treatment-experienced adult patients, who have
evidence of viral replication and HIV-1 strains resistant to a NNRTI and
other ARV agents.
This indication is based on Week 24 analyses from two randomized,
double-blind, placebo-controlled trials of INTELENCE. Both studies were
conducted in clinically advanced, three-class antiretroviral (NNRTI,
N[t]RTI, PI) treatment-experienced adults.
The following points should be considered when initiating therapy with
INTELENCE:
-- Treatment history and, when available, resistance testing, should guide
the use of INTELENCE.
-- The use of other active antiretroviral agents with INTELENCE is
associated with an increased likelihood of treatment response.
-- In patients who have experienced virologic failure on a
NNRTI-containing regimen, do not use INTELENCE in combination with
only N[t]RTIs.
-- The risks and benefits of INTELENCE have not been established in
pediatric patients or in treatment-naïve adult patients.
FDA accelerated approval procedures allow for earlier approval of drugs
that provide a meaningful therapeutic benefit over existing treatment for
serious or life-threatening diseases. The INTELENCE approval is based on
the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled
analysis of the DUET-1 and -2 studies. Longer-term data will be required
before the FDA can consider traditional approval for INTELENCE.
"It is very inspiring to our R&D organization to see an additional
compound so quickly emerge from our pipeline and reach patients who need
it," said Roger Pomerantz, M.D., FACP, President, Tibotec Research and
Development. "With one of the most robust virology research and development
programs in the industry, we are dedicated to continuing to deliver
innovative approaches in HIV management in the years to come."
"The addition of INTELENCE following the launch of our first
antiretroviral just two years ago is a significant milestone for Tibotec
Therapeutics," said Glenn Mattes, President, Tibotec Therapeutics. "In
partnership with Tibotec R&D, we are committed to continuing to bring new
options to people living with HIV."
The NNRTI Class
INTELENCE is the first new NNRTI to be introduced in nearly 10 years.
It is also the first NNRTI to show antiviral activity in patients with
NNRTI-resistant virus. NNRTIs block reverse transcriptase, a key enzyme the
HIV virus uses to replicate. NNRTI drug resistance occurs when HIV develops
mutations that partially or completely stop the NNRTI from binding to the
reverse transcriptase enzyme, causing the drug to lose effectiveness. As
with other HIV medications, patients can develop resistance to INTELENCE;
for more information see the resistance section below.
DUET-1 and -2 Study Design
The DUET-1 and -2 studies, identical in design but conducted in
different regions, assessed the 24-week efficacy and safety of INTELENCE in
combination with a background regimen (BR) in treatment-experienced adult
HIV-1 patients with documented evidence of NNRTI and PI resistance. They
were large randomized, controlled studies with a primary endpoint of less
than 50 copies/mL (known as undetectable viral load). IAS-USA treatment
guidelines define less than 50 copies/mL as the goal of therapy for
treatment-experienced patients when two or more potent drugs are
identified.
Patients with HIV-1 who were eligible for the DUET studies had a viral
load of greater than 5,000 copies/mL, while on a stable antiretroviral
therapy regimen for at least eight weeks and had evidence of at least one
NNRTI resistance-associated mutation, either at screening or from prior
resistance tests, as well as evidence of three or more primary PI mutations
(D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, V82A/F/L/S/T, I84V, N88S,
or L90M) at screening.
DUET-1 and -2 Efficacy
Participants in the DUET studies were randomized to receive INTELENCE
200 mg twice daily (599 patients) or placebo (604 patients), each given in
addition to a BR. For all patients, the BR included darunavir/ritonavir,
plus at least two investigator-selected antiretroviral drugs (N(t)RTIs with
or without enfuvirtide).
The 24-week pooled analysis of the DUET studies showed the following
results for INTELENCE plus BR vs. placebo plus BR:
-- Significantly more patients in the INTELENCE arm achieved undetectable
viral load (less than 50 copies/mL); 59.8 percent vs. 40.2 percent
[p 10
percent) of any intensity that occurred at a higher rate than placebo were
rash (16.9 percent vs. 9.3 percent) and nausea (13.9 percent vs. 11.1
percent). The most common treatment-emergent adverse reactions (Grade 2-4)
that occurred in greater than or equal to two percent of patients receiving
an INTELENCE-containing regimen were diarrhea, nausea, abdominal pain,
vomiting, fatigue, peripheral neuropathy, headache, rash, and hypertension.
Additional Important Safety Information
INTELENCE does not cure HIV infection or AIDS, and does not prevent
passing HIV to others.
-- Severe and potentially life-threatening skin reactions, including
Stevens-Johnson Syndrome, hypersensitivity reaction, and erythema
multiforme, have occurred (< 0.1 percent) in patients taking INTELENCE.
Treatment with INTELENCE should be discontinued and appropriate therapy
initiated if severe rash develops.
-- In general, in clinical trials, rash was mild to moderate, occurred
primarily in the second week of therapy, and was infrequent after Week
4. Rash generally resolved within 1-2 weeks on continued therapy.
Discontinuation rate due to rash was two percent.
-- Redistribution and/or accumulation of body fat have been observed in
patients receiving antiretroviral (ARV) therapy. The causal
relationship, mechanism, and long-term consequences of these events
have not been established.
-- Immune reconstitution syndrome has been reported in patients treated
with ARV therapy, including INTELENCE.
-- INTELENCE should be used with caution in patients with severe hepatic
impairment (Child-Pugh class C) as pharmacokinetics of INTELENCE have
not been evaluated in these patients.
Drug Interactions
-- INTELENCE should not be co-administered with the following ARVs:
tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir,
full-dose ritonavir (600 mg bid), protease inhibitors administered
without ritonavir, and other NNRTIs.
-- INTELENCE should not be co-administered with carbamazepine,
phenobarbital, phenytoin, rifampin, rifapentine, rifabutin (when part
of a regimen containing protease inhibitor/ritonavir) or products
containing St. John's wort (Hypericum perforatum).
-- INTELENCE and lopinavir/ritonavir should be co-administered with
caution.
-- Coadministration of INTELENCE with other agents such as
substrates, inhibitors, or inducers of CYP3A4, CYP2C9, and/or CYP2C19
may alter the therapeutic effect or adverse events profile of INTELENCE
or the co-administered drug(s). This is not a complete list of
potential drug interactions.
Please see full Prescribing Information for more details, available at
http://www.INTELENCE-info.com.
Patient Access to INTELENCE
INTELENCE is expected to be available at the wholesale level in the
U.S. within one week.
Martin Delaney of the Fair Pricing Coalition said, "Tibotec
Therapeutics continues to demonstrate real leadership in the pharmaceutical
industry by pricing INTELENCE fairly and responsibly. We applaud Tibotec's
responsible corporate behavior and expect to see the drug quickly accepted
on all formularies."
"With the introduction of INTELENCE, Tibotec Therapeutics has
demonstrated exceptional leadership in working with the HIV community in an
effort to address pricing and access issues. Tibotec has repeatedly
recognized the necessity of responsibly pricing HIV products and should be
commended for its leadership in this regard," said Lynda Dee from the AIDS
Treatment Activist Coalition.
Tibotec Therapeutics
Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.,
headquartered in Bridgewater, N.J., is dedicated to delivering innovative
virology therapeutics that help healthcare professionals address serious
unmet needs in people living with HIV.
Tibotec Pharmaceuticals Ltd.
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a
pharmaceutical research and development company. The Company's main
research and development facilities are in Mechelen, Belgium with offices
in Yardley, PA. Tibotec is dedicated to the discovery and development of
innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet
medical need.
Applications for approval of INTELENCE have also been submitted to the
European Agency for the Evaluation of Medicinal Products (EMEA) and with
regulatory authorities in Canada, Switzerland, Russia and Australia.
Ortho Biotech Products, L.P. and Tibotec Pharmaceuticals Ltd. are
subsidiaries of Johnson & Johnson.
Forward-Looking Statement
This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995. These statements are
based on current expectations of future events. If underlying assumptions
prove inaccurate or unknown risks or uncertainties materialize, actual
results could vary materially from Tibotec Pharmaceuticals Ltd.'s
expectations and projections. Risks and uncertainties include general
industry conditions and competition; economic conditions, such as interest
rate and currency exchange rate fluctuations; technological advances and
patents attained by competitors; challenges inherent in new product
development, including obtaining regulatory approvals; domestic and foreign
health care reforms and governmental laws and regulations; and trends
toward health care cost containment. A further list and description of
these risks, uncertainties and other factors can be found in Exhibit 99 of
Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended
December 31, 2006. Copies of this Form 10-K, as well as subsequent filings,
are available online at http://www.sec.gov, http://www.jnj.com or on request from Tibotec
Pharmaceuticals Ltd. or Johnson & Johnson. Tibotec Pharmaceuticals Ltd.
does not undertake to update any forward-looking statements as a result of
new information or future events or developments.
Tibotec Therapeutics
http://www.INTELENCE-info.com
View drug information on Intelence.
FDA aprobã INTELENCE (TM) (etravirine) Combinaþie Tratamentul pentru HIV - FDA Approves INTELENCE(TM) (etravirine) For HIV Combination Therapy - articole medicale engleza - startsanatate