Strug­gling in R&D, GSK lines up an FDA pitch on COPD with mixed da­ta

One of the few things that Glax­o­SmithK­line’s phar­ma R&D group got right in the last few years was mepolizum­ab, ap­proved for se­vere asth­ma in 2015 and sold as Nu­cala. And now, with ri­vals look­ing to com­pete over mar­ket turf in its core res­pi­ra­to­ry field, in­ves­ti­ga­tors have mapped out a shot at an ex­pan­sion in­to the COPD mar­ket for pa­tients at high risk of ex­ac­er­ba­tions.

But hit­ting that goal will re­ly on shaky da­ta, with plen­ty of holes in the ev­i­dence and a heavy re­liance on a bio­mark­er for dis­ease sever­i­ty.

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