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Biogen Launches High-Dose Spinraza Trial In Evrysdi Treated Patients: What You Need To Know

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  • Biogen Inc's (NASDAQ: BIIB) Spinraza (nusinersen), spinal muscular atrophy (SMA) drug launched in early 2017, faces new competition from Roche Holdings AG's (OTC: RHHBY) oral entrant Evrysdi (risdiplam).

  • Biogen has unveiled plans to test Spinraza in patients who've already been treated with Evrysdi.

  • Spinraza is already approved as a 12-mg dose, and the new trial will test loading doses of 50 mg two weeks apart plus maintenance doses of 28 mg every four months for about 2.5 years. Enrollment will start in 2021.

  • Biogen is already testing a higher dose of Spinraza in another trial called DEVOTE study.

  • Evrysdi's dosing maxes out at 5 mg when patients reach 20 kilograms in weight, Biogen said. The data suggest patients' exposure to the drug diminishes as they grow, Biogen says.

  • "We believe that lower drug exposure may be contributing to less-than-optimal treatment outcomes for some patients treated with Evrysdi," Biogen's chief medical officer Maha Radhakrishnan, M.D., said in a statement. "The ASCEND study seeks to understand if nusinersen may address that unmet medical need and will help inform the future of SMA treatment, with the hope of improving patients' outcomes for the long term."

  • The trial will assess patients' scores on the Revised Upper Limb Module measurement range. Other outcomes will look at safety, caregiver burden, and scores on the Hammersmith Functional Motor Scale Expanded metric.

  • Investigators will enroll up to 135 patients.

  • Price Action: BIIB shares are up 1.87% at $301.47 during the market session on the last check Wednesday.

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