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FDA
Gives Priority Review Status to Roche's New Formulation of Invirase
Roche
announced today that the US Food and Drug Administration (FDA) has
granted priority review status to the New Drug Application (NDA)
for a 500 mg tablet formulation of its HIV protease inhibitor, Invirase
(saquinavir hard gel). Following is an excerpt from the announcement:
If approved
by FDA, the new formulation of Invirase will simplify dosing regimens
by reducing pill count for each dose by more than half (from five
pills to two, twice-daily). The priority review designation establishes
a target six-month review period for the Invirase NDA.
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.
The FDA approved
Invirase 1000 mg for use in combination with ritonavir 100 mg and
other anti-HIV drugs in December 2003. Co-administering Invirase
with ritonavir (Norvir)provides therapeutic blood levels of the
drug and enables simplified, twice-daily dosing.
The Roche filing
is based on a bioequivalence study demonstrating that two 500 mg
tablets of Invirase, together with 100 mg of ritonavir, achieve
similar levels of Invirase in the blood as five Invirase 200 mg
capsules with 100 mg ritonavir.
"We are
very pleased that the FDA has granted an expedited review of the
Invirase 500 mg tablet, which could mean faster access for patients
to a simpler saquinavir dosing regimen," said Malte Schutz,
M.D, Medical Director, Roche. "Roche has an ongoing commitment
to developing Invirase. A comprehensive clinical program will begin
this year to further define the role of the 500 mg tablet in the
treatment of HIV."
Invirase boosted
with ritonavir is listed as a recommended component of initial antiretroviral
regimens in the new International AIDS Society-USA antiretroviral
guidelines. The guidelines, published in the July 14 issue of the
Journal of the American Medical Association (JAMA), gave
boosted Invirase a 1A rating, which is the highest position in the
guidelines based on strength of clinical evidence.
The FDA-approved
dosing for boosted Invirase is 1000 mg of Invirase (five 200 mg
capsules) in combination with ritonavir 100 mg, twice a day. Ritonavir
should be taken at the same time as Invirase. Invirase and ritonavir
should be taken within 2 hours after a meal.
Invirase website:
www.invirase.com
More
saquinavir articles on HIV and Hepatitis.com
8/18/04
Sources
Roche Laboratories.
Investigational Formulation of Invirase Granted Priority Review
Status by US FDA. News Release. August 17, 2004.
www.invirase.com
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