Well GNLB bit the dust today:
V. Final Conclusion
In Study 94-01, efficacy of GL701 was not demonstrated over placebo by any of the two primary endpoints (responder rate and percent decrease in predisone dose). For responder rate, although GL701 100 mg and 200 mg groups showed numerical advantage over placebo, no statistical significance was found. For percent decrease in predisone dose, placebo showed numerical advantage over the GL701 groups by mean.
In Study 95-02, although GL701 200 mg showed numerical advantage over placebo in responder rate, but no statistically significance was demonstrated. The dropout rates due to adverse events and lack of efficacy were both higher in the GL701 group. Therefore, when dropouts due to treatment failures were treated as non-responders, the numerical advantage of GL701 200 mg was mitigated (see reviewer’s comment on Section IV.2.iii).
As discussed in Section IV.1, the result of the post-hoc subgroup (baseline SLEDAI>2) analysis in Study 94-01 did not provide a robust base for generating the hypothesis that GL701 is efficacious in patients with baseline SLEDAI>2. Further, in Study 95-02, although GL701 200 mg showed larger numerical advantages over placebo in responder rate in the subgroup with baseline SLEDAI>2 than in the overall ITT population, the advantages were not statistically significant. Therefore, additional data is needed in supporting the efficacy of GL701 200 mg in the subgroup with SLEDAI>2.
fda.gov
I haven't followed them for years, so I don't know the details of how the company's version is different than the above conclusion.
Peter |
