Baricitinib, the artist formerly known as
LY3009104 / INCB028050 (a novel oral inhibitor of JAK1/2), made me very
enthusiastic at the ACR 2012 Meeting. A year ago there had only been a study
telling me not to worry about cholesterol in patients receiving baricitinib.
What do we have now? A phase 2b study from Japan. And that's all, folks!
Y. Tanaka
and colleagues [THU0149] presented the following study: "EFFICACY AND SAFETY OF BARICITINIB IN JAPANESE
RHEUMATOID ARTHRITIS PATIENTS AT 12 WEEKS". Conclusions: "Clinical efficacy was demonstrated in this Phase 2b
study of baricitinib in combination with background MTX in Japanese RA pts
through 12 weeks. Safety signals observed through 12 weeks were consistent with
a previous study of baricitinib in non-Japanese pts with RA." Nothing to
say against this study. Everything is fine, but it only tells us little more
than what we already know.
We are
desperately waiting for a phase 3 study! I've talked to the
Lilly people and they told me that phase 3 studies haven't completed
recruiting. So we still have to wait for these important studies.
I had already thought that FDA and EMEA are
getting stricter in applying drug efficiency and safety requirements as seen
after last year's ruling of EMEA concerning tofacitinib; the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
had adopted a negative opinion for Xeljanz® (tofacitinib). Maybe the current
phase 3 studies need more time than expected to make them watertight. Despite
my new worries and disappointments I hope that baricitinib will make it to the
market.
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