Biogen: Research Supports Development of Investigational Higher Dose of Spinraza in Spinal Muscular Atrophy
June 10 2021 - 8:48AM
Dow Jones News
By Michael Dabaie
Biogen Inc. said new research supports continued development of
an investigational higher dose of Spinraza in spinal muscular
atrophy.
Analysis of data from Phase 2 and Phase 3 studies in children
with infantile-onset SMA suggests that a higher dose of Spinraza
may lead to a clinically meaningful increase in the Children's
Hospital of Philadelphia Infant Test of Neuromuscular Disorders
score beyond what was already observed with the 12 mg approved
dose.
The data are being presented at the virtual Cure SMA Research
& Clinical Care Meeting taking place June 9 to 11.
These findings reinforce the scientific rationale for evaluating
a higher dose of Spinraza in the ongoing Devote Phase 2/3 study,
Biogen said.
The company said it is presenting data reinforcing the long-term
efficacy of Spinraza in a broad range of people with SMA
An analysis of data from a study shows 92% of patients who
initiated Spinraza treatment as pre-symptomatic infants maintained
the ability to swallow after a median of 3.8 years. In this
analysis, study participants were consistently rated by their
caregiver as, on average, never to rarely experiencing difficulty
for the majority of measures related to general feeding, drinking
liquids and eating solid foods, Biogen said.
In addition, post-hoc data from extension studies indicate
children and teens with later-onset SMA showed improvement in
walking distance over five years of Spinraza treatment and
stabilization in fatigue, the company said.
Biogen licensed the global rights to develop, manufacture and
commercialize Spinraza from Ionis Pharmaceuticals Inc.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
June 10, 2021 08:36 ET (12:36 GMT)
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