FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA re­mains silent on or­phan drug ex­clu­siv­i­ty in the wake of a con­tro­ver­sial court case, the agency con­tin­ues to hand out new des­ig­na­tions. The lat­est: Al­ger­non Phar­ma­ceu­ti­cals’ ex­per­i­men­tal lung dis­ease drug ifen­prodil.

The Van­cou­ver-based com­pa­ny an­nounced on Mon­day that ifen­prodil re­ceived or­phan des­ig­na­tion in id­io­path­ic pul­monary fi­bro­sis (IPF), a chron­ic lung con­di­tion that re­sults in scar­ring of the lungs.  Most IPF pa­tients suf­fer with a dry cough, and breath­ing can be­come dif­fi­cult.

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