In drug-development news in early June, one drug was approved for use
in patients with relapsed cases of chronic hepatitis C, and a trial of a drug
being testing to prevent diabetes was halted.
- The Food and Drug Administration approved the use of Schering-Plough's
Rebetron for the treatment of chronic hepatitis C in patients with compensated
liver disease who have relapsed following therapy with alpha interferon. The
FDA's decision was based in part on data showing that Rebetron, a therapy that
combines Intron A (interferon alfa-2B) and Rebetol (ribavirin), resulted in a
tenfold increase in the number of patients whose hepatitis C virus was
eradicated compared to patients receiving Intron A alone. Six months following
treatment, 79 of 173 patients (46%) who received Rebetron and eight of 172
patients (5%) who received Intron had undetectable virus levels.
- The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) stopped testing whether Rezulin (troglitazone) can be used to prevent
or delay type 2 diabetes in people with impaired glucose tolerance. The trial
was discontinued after one of 585 participants in the study developed liver
failure, required a liver transplant, and subsequently died. The NIDDK reported
that "drug-induced toxicity was probably the cause of liver failure."
However, the action does not pertain to patients who take Rezulin for the
treatment of type 2 diabetes, according to Warner-Lambert, whose Parke-Davis
unit sells the drug. "Patients currently taking Rezulin for type 2
diabetes can continue to take this therapy with confidence,"
Warner-Lambert said in a statement. Reports indicated that Warner-Lambert may
still be interested in testing whether the drug also can prevent diabetes.
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