Biogen Inc. BIIB announced that it has initiated a phase II/III study on its spinal muscular atrophy (SMA) drug Spinraza (nusinersen). The DEVOTE study will evaluate a higher dose of Spinraza to see whether it can provide greater efficacy for the treatment of SMA.
Based on the long-term safety profile and proven efficacy of Spinraza, the DEVOTE study will also evaluate the safety and tolerability of the drug when administered at a higher dose. Moreover, long-term data from the SHINE study showed that treatment with Spinraza demonstrated improvements in or stabilization of motor function in patients aged 21, who are treated for up to almost six years.
Shares of Biogen have lost 21.9% so far this year, underperforming the industry’s decline of 1.1%.
We remind investors that the FDA approved Spinraza in late 2016 for treating both pediatric and adult patients with SMA. Subsequently, in June 2017, the drug was approved in the EU for the same indication.
Notably, Biogen licensed the global rights to develop, manufacture and commercialize Spinraza from Ionis Pharmaceuticals IONS, a leader in antisense therapeutics.
Spinraza is the first and the only treatment approved for SMA in the United States. The drug has performed beyond expectations witnessing a strong patient uptake in the United States and internationally, and has now become the standard of care in SMA. The drug generated sales of little more than $1 billion during the first of half of 2019, reflecting year-over-year growth of almost 28%.
Notably, Novartis’ NVS oral gene therapy for SMA Type 1 — Zolgensma — was approved by the FDA for use in children less than 2 years old in May 2019. Meanwhile, Roche RHHBY and PTC Therapeutics are also evaluating their candidate risdiplam in a broad range of patients with SMA, which if successfully developed and approved, may compete with Spinraza in the future.
Biogen currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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