FDA Grants Priority
Review for Merck's Investigational HIV Integrase Inhibitor Raltegravir (Isentress)
On
June 27, Merck & Co. announced that the U.S. Food and Drug Administration
(FDA) has granted priority review status for the company's experimental HIV integrase
inhibitor raltegravir (brand
name Isentress, formerly MK-0518). Raltegravir is the first agent in this
novel antiretroviral drug class to be considered for approval.
Below
is an excerpt from Merck's press release announcing the FDA's decision:
FDA
Priority Review Granted for Isentress (raltegravir), Merck's Investigational Integrase
Inhibitor for HIV
Investigational
Integrase Inhibitor a New Class of Oral HIV Medication
WHITEHOUSE
STATION, N.J. -- June 27, 2007 08:00 AM EDT -- (BUSINESS WIRE) -- Merck &
Co., Inc. (NYSE: MRK) announced today that the U.S. Food and Drug Administration
(FDA) has accepted the New Drug Application (NDA) for Isentress (raltegravir,
previously known as MK-0518). Data in the NDA support the proposed use of Isentress
in combination with other antiretroviral agents for the treatment of HIV-1 infection
in treatment-experienced patients with evidence of HIV-1 replication despite ongoing
antiretroviral therapy (ART).
The
FDA granted Isentress priority review status, a designation for investigational
products that address unmet medical needs. Under the priority review designation,
the FDA is expected to review and act on the NDA for Isentress within six months
of submission. Merck anticipates FDA action by mid-October and as planned is also
moving forward with regulatory filings in countries outside of the United States.
If
approved, Isentress would be the first in a new class of antiretroviral agents
called integrase inhibitors that inhibit the insertion of HIV DNA into human DNA.
Inhibiting integrase from performing this essential function blocks the ability
of the virus to replicate and infect new cells. There are drugs in use that inhibit
two other enzymes critical to the HIV replication process -- protease and reverse
transcriptase -- but currently no approved drugs inhibit integrase.
"Isentress
underscores Merck's commitment to developing and marketing medications that address
unmet medical needs," said Peter S. Kim, PhD, president, Merck Research Laboratories.
"Isentress is a novel approach for treatment-experienced patients with HIV,
a population in need of additional options."
The
application included data from Phase II and Phase III clinical trials in which
Isentress was used in combination with optimized background therapy (OBT) in treatment-experienced
HIV patients failing ARTs who were infected with virus resistant to at least one
drug in each of the three available classes of oral ARTs.
The
formulation of Isentress under review is a single 400mg tablet dosed twice daily
without regard to food and which does not require boosting with ritonavir.
Merck
also is conducting ongoing clinical trials of Isentress in the treatment-naive
(previously untreated) HIV population.
Expanded
Access Program
Isentress
is currently available, at no charge, to qualified patients through an expanded
access clinical research program, EARMRK. The global program provides early
access to Isentress for patients who are resistant to existing classes of antiretroviral
medications and who require an HIV treatment regimen containing a medication to
which they may not be resistant.
06/29/07
Sources
Merck
& Co. FDA Priority Review Granted for Isentress (raltegravir), Merck's Investigational
Integrase Inhibitor for HIV. Press release. June 27, 2007.
