MDR TB drug by Ot­suka reaches In­dia

BioSpectrum (India) - - COMPANY NEWS -

Ja­panese drug maker Ot­suka Phar­ma­ceu­ti­cal has granted US phar­ma­ceu­ti­cal firm My­lan’s sub­sidiary an ex­clu­sive li­cense to sup­ply to In­dia and South Africa a drug to treat pa­tients with pul­monary multi-drug re­sis­tant tu­ber­cu­lo­sis (MDR TB). The agree­ment is ex­pected to speed up In­dia’s ac­cess to the po­ten­tially life-sav­ing drug, which had not been made avail­able in the coun­try de­spite Ot­suka hav­ing re­ceived a patent for it back in 2011.

The Drug Con­troller Gen­eral of In­dia (DCGI), In­dia’s apex drug reg­u­la­tor, has granted My­lan’s sub­sidiary ap­proval for the drug, ac­cord­ing to a re­lease by the com­pany. The drug, de­la­manid, was dis­cov­ered and devel­oped by Ot­suka.

The Re­vised Na­tional Tu­ber­cu­lo­sis Con­trol Pro­gramme (RNTCP) will now be­gin draft­ing the pro­to­col to ad­min­is­ter de­la­manid with other drugs to pa­tients with MDR TB and iden­tify sites where the drug will be rolled out. My­lan will use clin­i­cal data from these sites to con­duct a post mar­ket­ing sur­vey, af­ter which DCGI may give them per­mis­sion to in­tro­duce it in the pri­vate mar­ket.

The govern­ment in­tends to enter into dis­cus­sions with My­lan to en­sure that de­la­manid re­mains af­ford­able to In­dia. The only other drug avail­able in In­dia for pa­tients with MDR TB, a grow­ing is­sue in the coun­try, is be­daquiline by John­son & John­son. This drug was in­tro­duced last year and is also sup­plied to a lim­ited num­ber of pa­tients through the govern­ment's con­di­tional ac­cess pro­gramme.

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