US health regulator extends review of Biogen’s ALS drug
Biogen said it had submitted responses to the FDA's information requests, which the agency said would require additional time for review and set a new target action date of 25th April, 2023
The US Food and Drug Administration (FDA) has extended the review of Biogen’s experimental treatment for an inherited form of Amyotrophic Lateral Sclerosis (ALS) by three months, the company said yesterday.
Biogen said it had submitted responses to the FDA’s information requests, which, the agency said, would require additional time for review and set a new target action date of 25th April, 2023.
The agency had accepted Biogen’s application for the drug, Tofersen, under its accelerated approval pathway in July this year, with an approval decision expected by 25th January.
Last year, the drug had failed to meet the main goal of a late-stage study and did not show statistically significant improvement in the functional status of patients with fast-progressing ALS.
Last month, Biogen released new analysis that showed that longer-term use and an early initiation of Tofersen was effective in slowing disease progression.
ALS, also known as Lou Gehrig’s disease, breaks down nerve cells in the brain and spinal cord that make muscles work, leading to progressive paralysis and death. Its cause is largely unknown.
Biogen is seeking approval of tofersen for ALS patients with mutations in a specific gene that leads to accumulation of toxic levels of a protein called SOD1.
Edits by EP News Bureau