d4T Approval: FDA Advisory Committee Meeting, May 20

The Antiviral Drug Products Advisory Committee, a panel of
outside experts convened by the U.S. Food and Drug
Administration, will hold a public hearing on whether d4T
(generic name stavudine, brand name Zerit) should be given
accelerated approval on the basis of currently available
data. The hearing, which includes times for public
participation, is scheduled for 7:30 a.m. to 4 p.m. on May
20, at the Parklawn Building, conference rooms D and E, 5600
Fishers Lane, Rockville, Maryland. This committee will not
make the final decision, but will make a recommendation which
is almost always followed by the FDA. The committee is likely
to vote on its recommendation at the end of the meeting that
day.

Our understanding is that the developer, Bristol-Myers
Squibb, will be asking for accelerated approval -- approval
based mainly on the results of T-helper and viral tests, and
given on the condition that additional research continues in
order to obtain statistical proof of clinical benefit.

Comment

We have not seen the data which will be presented at the
hearing, and therefore cannot take a position on whether the
drug should be approved.

Some activists are concerned that the drug may be rejected
even if the data is good, due to a more conservative make-up
of the committee, and also due to general disappointment with
the followup research after accelerated approval of ddC --
even though ddC was developed by a different company. If this
happens, the fear is that, in effect, there will be no
accelerated-approval mechanism left.

Other activists believe that certain possible side effects of
d4T, such as sleep disturbances and depression, have not been
adequately recorded. They are likely to ask that
neuropsychiatric studies of any such effects be required as a
condition for accelerated approval.