| December
16, 2003 La
Jolla Pharmaceutical (NASDAQ: LJPC) has submitted an NDA to
the FDA for Riquent for specific, kidney-related, management
of patients with lupus (systemic lupus erythematosus, SLE).
The company is seeking Riquent approval for the reduction of
levels of antibodies to double-stranded DNA (dsDNA) in
patients with lupus. Such reduction has been associated with
fewer flares of lupus related kidney inflammation (lupus
nephritis).
Publicly
available data, including recent data presented at the
American College of Rheumatology meetings, leave significant
concerns that Riquent will not be approved in a timely manner.
In the absence of a more substantive data set, LJPC plans to
argue that approval is warranted because of clinically and
statistically significant health-related quality of life (HRQOL)
improvements observed in the trial program. Although the 6-
and 12-month data derived from a well-validated HRQOL
investigational tool have been impressive, it remains
uncertain the degree to which substantive outcomes were truly
measured prospectively. Therefore, the probability of FDA
approval remains below average despite the current regulatory
climate favoring palliative medicines that do not necessarily
improve primary or clinical investigational goals. A more
appealing Riquent NDA submission would derive from a
successful new trial more clearly demonstrating prospective,
placebo-controlled, efficacy across as broad a range of HRQOL
or other clinical outcomes.
Phase
III investigation showed that lupus patients who experienced
sustained reductions (of at least 10%) in antibodies to dsDNA
reported improved HRQOL and experienced a lower risk of major
SLE flare compared with lupus patients not achieving sustained
reductions. The results corroborated those from prior phase
II/III investigation. A lower risk of renal flare was also
reported in these trials.
Riquent
is a mixture of four pieces of dsDNA, each 20 nucleotides in
length. The mixture is an analog of the DNA that simulates a B
cell-mediated autoimmune response in many lupus patients. In
theory, the drug stimulates B cells in lupus patients to
become tolerant to stimulation by their own DNA, dampening the
autoimmune response. |
|
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