24.02.2000 – 22:08
Correction: Bristol-Myers Squibb Receives First Approval in France for New Enteric Coated Formulation of VIDEX(R) (didanosine)
London (ots-PRNewswire) -
First One Capsule, Once a Day Anti-HIV Drug May Further Simplify Treatment for Patients
Bristol-Myers Squibb announced today that the French Health Authorities have approved a new formulation of the anti-HIV therapy, VIDEX(R) (didanosine), also known as ddI. The French approval is the first in the world for the new formulation. VIDEX capsules or "gelules gastro-resistantes," as they will be known in France, are a further improvement on the once daily formulation approved in the European Union and the United States last year. VIDEX capsules contain enteric coated granules designed to protect didanosine, the active ingredient in VIDEX, from degrading until it has passed through the stomach, thus eliminating the need for buffer. VIDEX capsules will also reduce pill burden from two tablets a day to a single capsule taken once a day -- a first for antiretrovirals.
The French approval of VIDEX(R) (didanosine) capsules forms the basis of a mutual recognition application in the other 14 member states of the European Union. Once the procedure starts, the member states have 90 days to evaluate the dossier and recognize the French approval.
"Given the adherence challenges that people living with HIV face, it is always good news when an effective HIV therapy like VIDEX is made easier for patients to take and tolerate," said Steven Schnittman, M.D., Group Director, Infectious Disease Clinical Research, Bristol-Myers Squibb. "We are optimistic that this easy-to-take formulation will help with patient adherence, thus increasing the prospects for patients achieving and maintaining viral suppression."
Today's antiretroviral drug regimens can be complex and difficult to manage. A patient's "anti-HIV cocktail" can consist of as many as four drugs with different dosing requirements (times per day, with or without food, with or without other medicines, etc.) and carry a total pill burden of up to 20 pills per day. Unpleasant and serious side effects also challenge the patient's ability to adhere to the prescribed treatment regimen. Still, patients need to adhere to the prescribed treatment regimen in order to extract the full benefit from it.
"Since improved adherence can mean as much to successful antiretroviral treatment as a completely new anti-HIV drug, patients are continuously looking for therapies that are easier to take and easier on them," said Professor Jacques Reynes, M.D., Gui de Chauliac Hospital, Montpellier, France. "The new VIDEX is a significant improvement over the current formulation. The VIDEX capsule does not contain buffer and should reduce gastro-intestinal side effects like nausea in my patients."
After nearly seven years on the market, VIDEX remains one of the most potent antiretroviral therapies. VIDEX has been extensively studied in different populations of HIV-infected patients throughout the world and in "HIV cocktail" combinations with approved and experimental drugs. When combined with other antiretrovirals, VIDEX reduces viral load and increases CD4 cell count, the key indicators of efficacy in fighting HIV.
Today's announcement closely follows the New Drug Application (NDA) made for VIDEX(R) (didanosine) capsules with the United States Food and Drug Administration (FDA) on January 31, 2000. As part of the submission, Bristol-Myers Squibb has requested expedited review. In 1999, the French Health Authorities approved and the other EU member states mutually recognized once daily dosing of VIDEX and a new strength 200-mg tablet. VIDEX is the only nucleoside analogue reverse transcriptase inhibitor (NRTI) approved for once daily dosing.
VIDEX has been developed by Bristol-Myers Squibb since 1988. VIDEX received marketing clearance in the European Union in 1991 for the treatment of HIV/AIDS and is marketed by Bristol-Myers Squibb in over 70 countries around the world.
Bristol-Myers Squibb is committed to research and development of treatments for HIV/AIDS. In addition to VIDEX, BMS also markets ZERIT(R) (stavudine), also known as d4T, a nucleoside analog reverse transcriptase inhibitor (NRTI) approved for the treatment of HIV. The Company also has a protease inhibitor in development, BMS-232632 in Phase II clinical trials. Together with the Bristol-Myers Squibb Foundation, the Company has pledged $100 million over the next five years to help South Africa, Botswana, Namibia, Lesotho and Swaziland find sustainable solutions for women, children and communities suffering from the HIV/AIDS epidemic in their countries.
Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is a leading maker of innovative therapies for cardiovascular and metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The Company is a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin products.
For full prescribing information on VIDEX and ZERIT, please contact Patricia Doykos Duquette at +01-609-897-3077.
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