Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
PRNewswire - Wednesday December 2, 1998
"This rapid acceptance by state assistance programs is good news for the underinsured or uninsured people living with HIV and AIDS in those states," said Nicholas Teti, President, DuPont Pharmaceuticals. "We are pleased that people will have access to this important addition to antiretroviral therapy." The company's breakthrough drug, Sustiva, was approved in September by the U.S. Food and Drug Administration (FDA) as part of the agency's fast-track program. It is the first anti-HIV drug approved for once-daily dosing to be used in combination with other anti-HIV drugs in both adult and pediatric patients.
Since DuPont Pharmaceuticals launched the drug in September in the U.S., more than 30,000 patients have begun taking SustivaÖ (efavirenz). This includes over 8,000 patients who had been taking the drug as part of the company's Expanded Access Program, which provided free drug to those who will benefit from it. The company continues to actively enroll patients in the ongoing early access programs outside the U.S.
The accelerated approval of Sustiva was based on analysis of plasma HIV-RNA levels and CD4 cell counts in controlled studies of up to 24 weeks in duration. Patients should be counseled that nervous system symptoms and rash may occur early in treatment and generally resolve within two to four weeks with continued therapy with Sustiva. Women should not become pregnant while taking Sustiva because birth defects have been seen in animals given Sustiva.
DuPont Pharmaceuticals, a unit of DuPont's Life Sciences Enterprise, is a worldwide, research-based pharmaceutical company that markets its products under the DuPont Pharma name. The business focuses on research, development, and delivery of pharmaceuticals to treat unmet medical needs in the fight against HIV, cardiovascular disease, central nervous system disorders, cancer and arthritis-related disorders. DuPont Pharmaceuticals is also a leader in medical imaging.
SOURCE: DuPont Pharmaceuticals
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