FDA CLEARS FIRST IN NEW CLASS OF AIDS DRUGS CALLED HIV PROTEASE INHIBITORS
INVIRASE Will Be Available To Patients Within 48 Hours
NUTLEY, N.J., Dec. 7 /PRNewswire/ -- To respond to the immediate needs of people with AIDS, Roche Laboratories announced today that Invirase(TM) (saquinavir mesylate) capsules, the first in a new class of drugs called HIV protease inhibitors, will be on pharmacy shelves within 48 hours. The FDA has cleared Invirase for use in combination with nucleoside analogues such as AZT and HIVID(R) (ddC) for selected individuals with advanced HIV disease.
To ensure that every patient in the U.S. who can benefit from Invirase gets immediate and sustained access to the drug, irrespective of their financial situation, Roche has established the Roche HIV Therapy Assistance Program. This important program will make supplies of Invirase available to patients who are waiting to be approved for coverage and reimbursement through their existing insurance sources, and to patients who are uninsured and cannot afford to pay for the drug.
The decision to release Invirase for marketing was based on increases in CD4 counts (a measure of the immune system) in patients who initiated Invirase together with either AZT (in previously untreated patients) or HIVID (in patients previously treated with prolonged AZT therapy). Studies indicate that patients treated with combinations including Invirase have greater increases in CD4 counts and greater reduction of virus in the blood than patients given the same treatments without Invirase.
The clinical significance of changes in viral load has not been established. At this time, there are no data available from clinical trials evaluating the activity of Invirase in combination with nucleoside analogues other than AZT and HIVID. There are also no results available from clinical trials confirming the clinical benefit of regimens containing Invirase on survival or the clinical progression of HIV infection.
In clinical studies Invirase was well tolerated by most patients and reported adverse events were mostly of mild intensity. The most frequently reported adverse events, at least possibly related to Invirase treatment, and of at least moderate intensity included diarrhea (3.8 percent), abdominal discomfort (1.3 percent) and nausea (1.9 percent). Invirase does not appear to alter the pattern, frequency, or severity of adverse events associated with the use of HIVID and/or AZT. Invirase should not be administered concomitantly with rifampin and caution should be used when considering concomitant use of Invirase with rifabutin or other similar drugs. Physicians may consider using alternatives to such drugs when a patient is taking Invirase.
"The fact that there's a drug to be used in combination -- that is completely different -- is encouraging for people with AIDS, especially since it's a treatment with less side effects," said Gabriel Torres, M.D., medical director of the AIDS Center at St. Vincent's Hospital in New York.
Access for People With AIDS
"Access is a critical issue for AIDS physicians. We need to make new treatments available to our patients at the earliest opportunity, and to feel confident that patients will continue to have access to them in the longer term," said Dr. Torres.
The Roche HIV Therapy Assistance Program is available to health care providers and patients in the U.S. through the ASSIST Reimbursement Program. Services will include:
-- information about national and local insurance coverage for
-- contact with insurers to determine a specific patient's coverage
and benefits for Invirase;
-- informing payers, including Medicaid, commercial insurers and
AIDS Drug Assistance Programs (ADAPs) about Invirase;
-- helping callers with their insurance coverage by verifying and
explaining prior authorization and other procedures;
-- helping customers resolve denied or underpaid claims for Invirase
and assisting with appeals;
-- screening and enrolling eligible patients in the Medical Needs
Program (for patients without insurance or financial means) for
For more information about this program, patients are advised to speak with their physician or contact a local AIDS service organization.
The cost of Invirase will be $15.89 per day (wholesaler acquisition cost) at the recommended dose of 600 mg taken orally three times daily. Full prescribing information for Invirase is available upon request to Roche Laboratories.
Roche Laboratories of Nutley, N.J., is the pharmaceutical sales and marketing division of Hoffmann-La Roche Inc., and has a long history in the area of HIV which includes HIVID, Cytovene(TM), Roferon-A(R), and Bactrim(TM) as well as HIV diagnostics. Hoffmann-La Roche is a research-based health care company that is a member of the Roche Group with headquarters in Basel, Switzerland. Roche is a leading health care company dedicated to the research, development and delivery of diagnostic tests, treatments and services for people with life- threatening diseases.
/CONTACT: Joy Schmitt of Hoffmann-La Roche, 201-562-2202/
CO: Roche Laboratories; Hoffmann-La Roche Inc. ST: New Jersey IN: MTC SU: PDT
PS-PL -- NYTH021 -- 5666 12/07/95 09:58 EST
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|Date:||Dec 7, 1995|
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