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SAN DIEGO (AP) -- La Jolla Pharmaceutical Co. said Monday that,
based on the outcome of a meeting with the Food and Drug Administration
on Friday, its Riquent lupus renal disease treatment is unlikely
to receive accelerated approval.
La Jolla shares plunged 43 cents, or 35.8 percent, to 77 cents in
morning trading on the Nasdaq.
The company said it plans to maintain its ongoing clinical benefit
trial and expects to continue discussions with the FDA about ways
to enhance the trial, including the addition of a higher dose to
the study.
La Jolla said this decision follows a number of meetings with the
FDA since October 2004, when the company received an approvable
letter from the FDA for Riquent. The letter indicated that an additional
trial demonstrating clinical benefit would be required prior to
approval of Riquent and that the company's ongoing trial, initiated
in August 2004, would appear to satisfy this requirement.
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