Spinraza’s growth in the United States
Spinraza, Biogen’s (BIIB) SMA (spinal muscular atrophy) therapy, was approved by the FDA (U.S. Food and Drug Administration) on December 23, 2016. Like Alexion Pharmaceuticals’ (ALXN) Soliris, Vertex Pharmaceuticals’ (VRTX) Orkambi, and United Therapeutics’ (UTHR) Unituxin, Spinraza has also been granted orphan drug designation by the FDA.
Since Spinraza is the first approved drug for SMA, it witnessed robust demand trends in 1Q17. Biogen is also involved in further strengthening the infrastructure for the administration of the drug as well as improving patient access for the therapy.
In 88 sites across 36 US states, Spinraza is already being administered to patients. To date, most of these sites have delivered the drug to only one or two patients, but there are a few sites where up to ten patients have been dosed with the drug. Approximately 203 new sites have submitted start forms to get access to Spinraza.
If Biogen manages to boost the underlying demand for Spinraza, it may have a favorable impact on Biogen stock as well as the iShares Core S&P 500 (IVV). Biogen makes up about 0.31% of IVV’s total portfolio holdings.
International market growth
Through Biogen’s expanded access program, Spinraza will be administered to 353 type 1 SMA patients in international markets. Of these, 306 patients are from Europe. The expanded access program helps patients access drugs not yet approved and launched in their countries.
On April 21, 2017, Spinraza received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency. That increases the chances for regulatory approval in most European markets in the next few months. Biogen also expects to secure regulatory approval for Spinraza in Japan, Canada, and ten other countries in 2017.
In the next part of this series, we’ll look at the access strategy for Spinraza.