Project Inform cited in the press
PREZISTA Receives FDA Approval as Part of
HIV Combination Therapy
Hispanic PR Wire, June 30, 2006
www.hispanicprwire.com
(mention of Project Inform in bold below)
The U.S. Food and Drug Administration (FDA) has granted accelerated
approval to the anti-HIV medication PREZISTA(TM) (darunavir) tablets.
PREZISTA, a protease inhibitor previously known as TMC114, 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.
FDA accelerated approval procedures allow for earlier approval
of drugs that provide a meaningful therapeutic advantage over existing
treatment for serious or life-threatening diseases. This approval
is based on the 24-week analysis of HIV viral load and CD4+ cell
counts from the pooled analysis of the TMC114-C213 (POWER 1) and
TMC114-C202 (POWER 2) studies. Longer-term data will be required
before the FDA can consider traditional approval for PREZISTA.
“One of the greatest challenges in HIV care is finding therapies
for treatment-experienced patients,” said Michael S. Saag,
M.D., director of the AIDS Outpatient Clinic and the University
of Alabama at Birmingham Center for AIDS Research. “This is
an important new option for the thousands of people with HIV in
the United States who are resistant to more than one protease inhibitor.”
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/rtv)
and with other antiretroviral agents, is indicated for the treatment
of human immunodeficiency virus (HIV) infection in antiretroviral
treatment-experienced adult patients, such as those with HIV-1 strains
resistant to more than one protease inhibitor.
This indication is based on Week 24 analyses of plasma HIV RNA
levels and CD4+ cell counts from two controlled trials of PREZISTA/rtv
in combination with other antiretroviral drugs. Both studies were
conducted in clinically advanced, treatment-experienced (NRTIs,
NNRTIs, and PIs) adult patients with evidence of HIV-1 replication
despite ongoing antiretroviral therapy.
The following points should be considered when initiating therapy
with PREZISTA/rtv:
--Treatment history and, when available, genotypic or phenotypic
testing should guide the use of PREZISTA/rtv.
-- The use of other active agents with PREZISTA/rtv is associated
with a greater likelihood of treatment response.
-- The risks and benefits of PREZISTA/rtv have not been established
in treatment-naïve adult patients or pediatric patients.
“The Fair Pricing Coalition believes that Tibotec
Therapeutics has priced PREZISTA responsibly. This is a particularly
thoughtful move on the company's part since it recognizes the crisis
in funding faced by payers in and out of government,” said
Martin Delaney, on behalf of the Fair Pricing Coalition and Founding
Director, Project Inform. (Actual prices paid by individual payers
may vary.)
“PREZISTA is an important new medicine in HIV and Tibotec
Therapeutics and Tibotec R&D have demonstrated a true commitment
to putting the needs of patients first. We applaud them for their
efforts to make this product available and accessible to people
living with HIV in the United States,” said Howard Grossman,
M.D., Executive Director, American Academy of HIV Medicine.
