Bio­gen, Io­n­is win FDA OK for spinal mus­cu­lar at­ro­phy drug Spin­raza

Bio­gen $BI­IB and Io­n­is $IONS got an ear­ly Christ­mas present Fri­day evening as the FDA an­nounced that it had pro­vid­ed an ac­cel­er­at­ed ap­proval for Spin­raza (nusin­ersen), their new drug — and the first — for rare cas­es of spinal mus­cu­lar at­ro­phy.

Peak sales es­ti­mates hov­er around $2 bil­lion, with some of the new es­ti­mates com­ing in over $3 bil­lion by 2026.

“Our pre­vi­ous fore­cast in­clud­ed sales of $75mm in 2017 grow­ing to $2.8bn by 2026,” not­ed Leerink’s Ge­of­frey Porges in ear­ly No­vem­ber, with the ar­rival of more Phase III da­ta. “We now as­sume a launch in Q1 2017 from Q2 2017 pre­vi­ous­ly and our cur­rent fore­cast is for sales of $92mm in 2017 in­creas­ing to $1.56bn by 2020 and then $3.2bn by 2026.”

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