) recently presented new data on its lupus candidate,
epratuzumab, from an open-label extension study of the EMBLEM
phase IIb study. The extension study assessed the long-term
effects of epratuzumab on moderate-to-severe systemic lupus
erythematosus (SLE) in adults.
No new safety and tolerability signals were observed in this
two-year extension study. Moreover, epratuzumab's efficacy -
measured by fall in disease activity - was maintained during the
two year period. Secondary findings also pointed toward decreases
in corticosteroid use in patients receiving >7.5 mg/day of
epratuzumab for over two years.
The 12-week EMBLEM study had enrolled 227 patients with
moderate-to-severe SLE to find an appropriate dosing regimen for
epratuzumab by treating patients with either placebo or
epratuzumab in various dosages. The phase IIb extension study was
conducted to gain two-year open-label data.
Epratuzumab is in-licensed from
) and is currently in a phase III program.
The SLE market currently has products like Benlysta and
Benlysta was approved in Mar 2011 by the US Food and Drug
Administration (FDA) and is currently available in the US, Canada
and a number of European and other countries. In addition,
regulatory submissions are pending in other countries.
The SLE market is attracting a number of drug makers. Notable
among these is
), which collaborated with Resolve Therapeutics earlier this year
for the development of treatments for SLE and other autoimmune
diseases. Moreover, a large cap pharma company is developing
tabalumab for SLE in a phase III study, ILLUMINATE.
UCB carries a Zacks Rank #3 (Hold). Currently,
Salix Pharmaceuticals Ltd.
) looks well positioned with a Zacks Rank #1 (Strong Buy).
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