Valeant nose­dives on CRL for plaque pso­ri­a­sis, rais­ing con­cerns over tout­ed $1B pipeline

Valeant is suf­fer­ing an­oth­er hit this morn­ing as the FDA kicked back its ap­pli­ca­tion for a drug the phar­ma gi­ant tout­ed as one of sev­en “sig­nif­i­cant” prod­ucts meant to recharge the com­pa­ny’s rev­enue.

US reg­u­la­tors gave a thumbs down to Valeant’s Duo­brii, a lo­tion meant to treat plaque pso­ri­a­sis. The com­plete re­sponse let­ter (CRL) didn’t cite any de­fi­cien­cies when it came to clin­i­cal safe­ty or ef­fi­ca­cy, Valeant not­ed, but took is­sue with some phar­ma­co­ki­net­ic da­ta (how the body re­acts to a treat­ment, in­clud­ing du­ra­tion and in­ten­si­ty of a drug’s ef­fect). The com­pa­ny’s ex­pla­na­tion didn’t go fur­ther than that.

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