Ja­pan MHLW grants mar­ket­ing ap­proval for RA treat­ment

BioSpectrum (Asia) - - Regulatory News -

Eli Lilly and Com­pany and In­cyte Cor­po­ra­tion an­nounced that Ja­pan’s Min­istry of Health, La­bor and Wel­fare (MHLW) granted mar­ket­ing ap­proval for Olu­mi­ant (baric­i­tinib) 2-mg and 4-mg tablets for the treat­ment of rheuma­toid arthri­tis (RA) (in­clud­ing the prevention of struc­tural in­jury of joints) in pa­tients with in­ad­e­quate re­sponse to stan­dard-of-care ther­a­pies.

The Olu­mi­ant ap­proval is based on the re­sults of the baric­i­tinib devel­op­ment pro­gram, which in­cludes four phase 3 clin­i­cal tri­als en­rolling var­i­ous pop­u­la­tions of more than 3,000 mod­er­ate-to-se­vere RA pa­tients world­wide, in­clud­ing more than 500 Ja­panese pa­tients. In clin­i­cal stud­ies, baric­i­tinib has demon­strated sig­nif­i­cant im­prove­ment in the signs and symp­toms of RA com­pared to stan­dard-of­care ther­a­pies.

De­spite clin­i­cal ad­vances in the treat­ment of RA, some peo­ple do not achieve op­ti­mal con­trol of their dis­ease or they dis­con­tinue treat­ment due to lack of ef­fi­cacy or side ef­fects, which can lead to long-term dam­age and dis­abil­ity. The Ja­pan mar­ket­ing autho­riza­tion of Olu­mi­ant trig­gers a $15 mil­lion mile­stone pay­ment from Lilly to In­cyte, which In­cyte ex­pects to rec­og­nize, in full, in the third quar­ter of 2017.

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