) recently announced new regulatory filings with the US Food and
Drug Administration (FDA) and the European Medicines Agency (EMA)
for two additional indications for its drug, Cimzia (certolizumab
The company is looking to get Cimzia approved for the treatment
of adults with active psoriatic arthritis (PsA) and active axial
spondyloarthritis (axSpA). UCB's regulatory filings were based on
the phase III RAPID-PsA and RAPID-axSpA studies.
RAPID-PsA was a double-blind, placebo-controlled, phase III study
which showed improvements in the signs and symptoms of PsA
compared to placebo in adult patients with or without prior
anti-TNF (tumor necrosis factor) exposure.
RAPID-axSpA was a randomized, double-blind,
placebo-controlled, phase III study which showed that both dosing
regimens of Cimzia reduced the signs and symptoms of axSpA as
compared to placebo.
We note that UCB's Cimzia is currently approved in the US for
the treatment of moderate-to-severe rheumatoid arthritis patients
above 18 years and for reducing the signs and symptoms of Crohn's
disease (CD) and maintaining clinical response in
moderate-to-severe CD patients above 18 years, who have failed
Cimzia is also approved in the EU in combination with
methotrexate (MTX) for the treatment of moderate-to-severe active
rheumatoid arthritis in adults who have responded inadequately to
disease-modifying antirheumatic drugs (DMARDs), including MTX. In
case of intolerance to MTX or inappropriateness with MTX, Cimzia
can be given as monotherapy.
Cimzia sales went up 41% from the year-ago period to €334
million during the first nine months of 2012.
) Humira and
Johnson & Johnson
) Simponi are marketed drugs in the psoriatic arthritis
UCB carries a Zacks Rank #3 (Hold). Right now,
Lannett Company, Inc.
) looks more attractive with a Zacks Rank #1 (Strong Buy).
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