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Qalsody

All articles tagged with #qalsody

health3 years ago•3 min saved

"Challenges and Innovations in Neurological Treatments: ALS and MS Updates"

Neurologists, frustrated with the limited effectiveness of current treatments for amyotrophic lateral sclerosis (ALS), are rapidly adopting two new therapies, Relyvrio and Qalsody, despite the lack of real-world data. These medications, recently approved by the U.S. FDA, may delay disease progression and offer some hope to ALS patients. However, neurologists also expressed a high unmet need for more effective disease-modifying treatments that can alter the course of ALS. They have little knowledge of investigational treatments in development but remain hopeful for therapies with new mechanisms of action.

via ALS News Today|

#als #health #neurologists

health3 years ago•3 min saved

FDA approves new drug for rare form of ALS, Qalsody.

The FDA has approved Qalsody (tofersen), a new drug to treat a rare form of amyotrophic lateral sclerosis (ALS) caused by the SOD1 mutation, which affects only 2% of the ALS population. The drug has the potential to slow muscle degeneration by targeting SOD1 messenger RNA. Studies showed that the drug reduced plasma neurofilament light (NfL), a blood-based biomarker of axonal injury and neurodegeneration. The drug is given via a lumbar puncture with three doses in 14-day intervals, followed by monthly dosing. Biogen, which makes the drug, will still need to complete additional and larger studies on its effectiveness.

via ABC News|

#als #fda #health

health3 years ago•2 min saved

FDA approves Biogen's drug for rare form of ALS.

The FDA has approved Biogen's drug, Qalsody, for a rare genetic form of ALS that targets a mutation in the SOD1 gene. The drug will be priced "within a range comparable to other recently launched ALS treatments." Qalsody is the first conditional approval granted for a medication for ALS, despite uncertainty about its effectiveness. Biogen will be required to provide confirmatory evidence from ongoing clinical research to keep the drug on the market. Before Qalsody, only three ALS medications were approved in the United States, and they have not significantly altered the course of the disease.

via The New York Times|

#als #biogen #fda