It was partly funded by 2014's 'Ice Bucket Challenge.'
There is no known treatment for the disease, yet, and most patients live only two to five years after being diagnosed.
The clinical trial included 137 people with ALS disease and made them test Amylyx’s drug called Relyvrio. The results have demonstrated that subjects who took the drug lived nearly ten months longer than those who didn’t take it and the drug seemed to delay hospitalizations.With the FDA's approval of the drug, Relyvrio has become the third FDA-approved medicine for ALS.
“It’s hard to put into words how significant this approval is for the thousands of Americans who are living with ALS and their families,” said Larry Falivena, a member of the ALS Association Board of Trustees who was diagnosed with ALS in 2017. “The ALS community has proven that our advocacy can impact decisions that are being made about our health. We need new treatments as quickly as possible if we are going to turn ALS into a livable disease and eventually cure it.
However, the FDA took a surprising step by calling for a second advisory committee just six months later after Amylyx shared a second analysis of its trial results. The advisory committee changed its mind about the medicine during that meeting and decided to approve it, according to a report by
South Africa Latest News, South Africa Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
FDA approves treatment that ALS Ice Bucket Challenge helped fundIn 2014, people all over the world joined in on the ALS ice bucket challenge. It raised $115 million in donations, according to the ALS Association.
Read more »
Advocates Urge FDA to Ease Access to Abortion Pill for Miscarriage ManagementMedical and advocacy groups are urging the FDA to add miscarriage management as a use case for mifepristone, a drug commonly used in medical abortions, and ease the restrictions around who can prescribe it. Via 19thnews
Read more »
FDA Approves HIV-1 Treatment Ibalizumab for 30-Second IV PushThe medication was first approved by the FDA in 2018 for adults with multi-drug resistant HIV-1.
Read more »
FDA Approves Futibatinib for Certain Biliary Tract CancersFDAapproves futibatinib, to be used for patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma, through its accelerated approval program. OncTwitter MedTwitter
Read more »
Juul Prepares to Seek Financing for Potential Bankruptcy ProcessJuul Labs is expected as soon as this week to start discussions with lenders for financing that would carry the vaping company through a potential chapter 11 bankruptcy filing
Read more »