Monday, July 27, 1998
WASHINGTON - The unique medical and social nature of AIDS played an important role in last week's review of Isis Pharmaceuticals Inc.'s Vitravene by the ophthalmic drugs subcommittee of the Dermatologic & Ophthalmic Drugs Advisory Committee. The panel voted 5-2 to recommend approval of the antisense compound for cytomegalovirus (CMV) retinitis in AIDS patients (see BioCentury Extra, July 23).
The discussion of Vitravene illustrated the impact of AIDS in situations where trial data don't meet the usual requirements for FDA approval, but where panel members believe that a drug should be available to patients.
The debate also illustrated the effect that reimbursement issues can have on panelists' thinking about labeling for first- versus second-line therapy - although it remains to be seen how the FDA will decide the issue for ISIP (Carlsbad, Calif.).
Need vs. science
Several panel members said the number of patients who participated in ISIP's trials was too small - and potential problems interpreting the results raised by FDA were too serious - to conclude that the trials met the agency's usual criteria for "adequate and well-controlled."