Biogen
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Tofersen is the furthest along of four ASOs currently in clinical development for ALS and as such, there is quite a bit riding on the results of the VALOR trial which has an estimated completion date of August 31st, 2021.
The House Committee on Oversight and Reform announced plans to investigate the approval and pricing of the drug. Biogen, on its part, has defended its pricing.
The company said it will file a marketing application later this year for the drug under the FDA’s accelerated approval pathway.
The drug was approved on June 7 under the agency’s accelerated approval pathway, despite the agency’s Peripheral and Central Nervous System Drugs Advisory Committee voting against the drug in November 2020 and having been assured at that time the agency was not considering an accelerated approval.
It’s been a bumpy ride for Biogen as news swirls around its overall Alzheimer’s program… but not for its competitors with investigational therapies for that disease.
The Third Rock Ventures-backed startup has a pipeline of Treg therapeutics aimed at multiple sclerosis, type 1 diabetes and inclusion body myositis.
It was another busy week of clinical trial announcements. Here’s a look.
Three other drug contenders that work similarly to Biogen’s drug are currently in clinical trials and expecting data relatively soon.
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