FDA
APPROVES NEW DOSAGE STRENGTH FOR INTELENCE®
- New formulation reduces number of INTELENCE tablets taken
daily -
[Titusville,
NJ, January 3, 2011] - The U.S. Food and Drug Administration
(FDA) approved a label update to include a 200 mg formulation
of INTELENCE® (etravirine), a non-nucleoside reverse transcriptase
inhibitor (NNRTI) indicated for the treatment of human immunodeficiency
virus (HIV-1) in treatment-experienced adults with resistance
to an NNRTI and other antiretroviral (ARV) agents.
The
recommended oral dose of INTELENCE tablets is 200 mg (one
200 mg tablet or two 100 mg tablets) taken twice daily following
a meal. The new 200 mg product formulation is expected to
launch in the U.S. later this month, and the 100 mg tablet
will remain available. Patients who are unable to swallow
INTELENCE tablets whole may disperse the tablets in a glass
of water.
The
FDA granted accelerated approval to INTELENCE in January 2008,
and it has since been approved in more than 65 countries.
INTELENCE received traditional FDA approval in November 2009,
based on 48-week data from the DUET-1 and DUET-2 studies,
and is currently marketed in the U.S. by Tibotec Therapeutics,
a division of Centocor Ortho Biotech Products, L.P.
INTELENCE
Indication
INTELENCE, in combination with other antiretroviral agents,
is indicated for the treatment of HIV-1 infection in ARV treatment-experienced
adult patients who have evidence of viral replication and
HIV-1 strains resistant to an NNRTI and other ARV agents.
This indication is based on Week 48 analyses from two randomized,
double-blind, placebo-controlled trials of INTELENCE. Both
studies were conducted in clinically advanced, three-class
ARV (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 ARV agents with INTELENCE is associated
with an increased likelihood of treatment response.
In patients who have experienced virologic failure on an 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.
About
the DUET studies
The DUET studies, identical in design and conducted across
the Americas, Australia, Canada, Europe and Thailand, examined
the use of INTELENCE in combination with other ARV agents
in adult treatment-experienced HIV-1 patients with documented
resistance to NNRTIs and protease inhibitors (PIs). Participants
in the DUET studies were randomized to receive INTELENCE 200
mg twice daily or placebo, each given in addition to a background
regimen (BR). For all patients, the BR included darunavir/ritonavir,
plus at least two investigator-selected antiretroviral drugs
(N(t)RTIs with or without enfuvirtide).
Important
Safety Information
INTELENCE does not cure HIV infection or AIDS, and does not
prevent passing HIV to others.
Warnings
& Precautions
Severe
Skin and Hypersensitivity Reactions:
-
Severe, potentially life-threatening, and fatal skin reactions
have been reported in patients taking INTELENCE. These include
cases of Stevens-Johnson syndrome, toxic epidermal necrolysis,
and erythema multiforme
- Hypersensitivity reactions have also been reported and
were characterized by rash, constitutional findings, and
sometimes organ dysfunction, including hepatic failure
In
the DUET studies, Grade 3 and 4 rashes were reported in 1.3%
of patients receiving INTELENCE compared to 0.2% of patients
in the placebo arm. Discontinuation rate due to rash was 2.2%
in patients taking INTELENCE. Rash occurred most commonly
during the first 6 weeks of therapy
Discontinue INTELENCE immediately if signs or symptoms of
severe skin reactions or hypersensitivity reactions develop
(including, but not limited to, severe rash or rash accompanied
by fever, general malaise, fatigue, muscle or joint aches,
blisters, oral lesions, conjunctivitis, facial edema, hepatitis,
eosinophilia, angioedema)
Monitor clinical status including liver transaminases, and
initiate appropriate therapy
Delay in stopping INTELENCE treatment after the onset of severe
rash may result in a life-threatening reaction
Fat
Redistribution:
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
Use
in Specific Populations
Hepatic Impairment: 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
Pregnancy Category B: INTELENCE should be used
during pregnancy only if the potential benefit justifies the
potential risk. No adequate and well-controlled studies have
been conducted in pregnant women
Adverse
Reactions
The
most common adverse drug reactions (?2%) of at least moderate
intensity (?Grade 2) reported in patients taking INTELENCE
and that occurred at a higher rate compared with placebo were
rash (10% vs 3%) and peripheral neuropathy (4% vs 2%)
INTELENCE
should not be coadministered with the following ARVs: tipranavir/ritonavir,
fosamprenavir/ritonavir, atazanavir/ritonavir, full-dose ritonavir
(600 mg bid), protease inhibitors administered without low-dose
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)
Coadministration of INTELENCE with other agents such as substrates,
inhibitors, or inducers of CYP3A, CYP2C9, CYP2C19, and/or
P-glycoprotein may alter the therapeutic effect or adverse
reaction profile of INTELENCE or the coadministered drug(s)
This
is not a complete list of potential drug interactions
You
are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088
Please see full Prescribing Information for more details.
Full prescribing information is also available at www.INTELENCE-info.com.
About Tibotec Therapeutics
Tibotec Therapeutics, a division of Centocor Ortho Biotech
Products, L.P., headquartered in Titusville, N.J., is dedicated
to delivering innovative virology therapeutics that help healthcare
professionals address serious unmet needs in people living
with HIV.
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 Centocor Ortho Biotech Products,
L.P.'s and/or Johnson & Johnson'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
January 3, 2010. Copies of this Form 10-K, as well as subsequent
filings, are available online at www.sec.gov, www.jnj.com
or on request from Johnson & Johnson. Neither Centocor
Ortho Biotech Products, L.P. nor Johnson & Johnson undertake
to update any forward-looking statements as a result of new
information or future events or developments.
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