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Biogen Publishes P-III (VALOR) Study Results of Tofersen for the Treatment of Amyotrophic Lateral Sclerosis at NEJM

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Biogen Publishes P-III (VALOR) Study Results of Tofersen for the Treatment of Amyotrophic Lateral Sclerosis at NEJM

Biogen Publishes P-III (VALOR) Study Results of Tofersen for the Treatment of Amyotrophic Lateral Sclerosis at NEJM

Shots:

  • The company reported the results from the P-III (VALOR) study in 108 patients & OLE study in 95 patients evaluating the effects of tofersen (100mg) for ALS associated with a SOD1 mutation
  • The results showed a sustained reduction in SOD1 protein & neurofilament. The results also slowed the decline in clinical function, respiratory function, strength, and QoL with earlier initiation of tofersen
  • The US FDA has accepted the tofersen’s NDA for priority review & the PDUFA date is expected on Jan 25, 2023. The therapy is being evaluated in the P-III (ATLAS) study to evaluate tofersen & delay clinical onset when initiated in presymptomatic individuals with a SOD1 genetic mutation and biomarker evidence of disease activity

Ref: Biogen | Image: Biogen

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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