GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, Glax­o­SmithK­line’s Benlysta be­came the first bi­o­log­ic to win ap­proval for lu­pus pa­tients. Nine years on, the British drug­mak­er has un­veiled de­tailed pos­i­tive re­sults from a study test­ing the drug in lu­pus pa­tients with as­so­ci­at­ed kid­ney dis­ease — a post-mar­ket­ing re­quire­ment from the ini­tial FDA ap­proval.

Lu­pus is a drug de­vel­op­er’s night­mare. In the last six decades, there has been just one FDA ap­proval (Benlysta), with the field re­sem­bling a grave­yard in re­cent years with a string of fail­ures in­clud­ing UCB and Bio­gen’s late-stage flop, as well as de­feats in Xen­cor and Sanofi’s pro­grams. One of the main rea­sons the suc­cess has elud­ed re­searchers is be­cause lu­pus, akin to can­cer, is not just one dis­ease — it re­al­ly is a dis­ease of many dis­eases, not­ed Al Roy, ex­ec­u­tive di­rec­tor of Lu­pus Clin­i­cal In­ves­ti­ga­tors Net­work, an ini­tia­tive of New York-based Lu­pus Re­search Al­liance that claims it is the world’s lead­ing pri­vate fun­der of lu­pus re­search, in an in­ter­view.

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