FDA Votes to Approve Experimental ALS Drug

Photo: Chicago Tribune/Getty Images [via The Washington Post]

The Facts

  • After voting against approval back in March, a Food and Drug Admin. (FDA) advisory panel on Wed. voted 7-2 to recommend approval of an experimental ALS drug, coming with strong support from patients and advocates.

  • The medication, called AMX0035, is a combination of two older drugs: one being a prescription medication for liver disease and the other a dietary supplement used in traditional Chinese medicine.


The Spin

Narrative A

Between the current unmet needs of ALS patients and Amlyx's promise to withdraw the drug if shown ineffective, this was the right decision by the advisory panel. With no cure for this devastating disease and few other medications on the market, it's only fair that patients be given the chance to try and extend their lives as much as possible.

Narrative B

Though patients and advocates understandably want any and every possible treatment available, the FDA should be skeptical of a drug that hasn't completed its trials and a company's promise to voluntarily withdraw it from the market if it fails in order to receive approval. There's a reason it was declined in the past.


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