Manufacturer of experimental ALS treatment withdraws application for FDA approval

An experimental drug that has helped many ALS patients in trials is being pulled for approval from the Food and Drug Administration.The manufacturer of Nurown withdrew its application for approval on Wednesday and is instead going to attempt to raise money for another trial.Those trials, however, can take years, which many ALS patients don’t have.For years, Patty Manhardt has been fighting for any drug that could extend her life with ALS. Manhardt has three grown kids and now has her first grandchild to fight for.Nurown was the one drug that gave Manhardt hope. For some ALS patients, it has reversed ALS symptoms. Former Navy pilot Matt Bellina was able to stand on his own again.Despite powerful testimony in front of an FDA committee, where patients discussed regaining their ability to move and breathe on their own, only one member of the 19-member committee voted to support granting access to the drug four weeks ago.Before the FDA’s final vote in December, the maker of Nurown withdrew its application for approval.Instead, the makers of Nurown are going to try to raise money for another trial, but another trial means more waiting for people like Manhardt.”One of the saddest things in this is if Congress can’t help us, if the FDA doesn’t change their mind, I will see my friends die and they will see me die,” Manhardt said.Right now, around 30,000 people have ALS, also known as Lou Gehrig’s disease.Even though the maker of Nurown said it’s already working on the next steps to get funding for another trial, most trials can take three to five years to complete.

https://www.wlwt.com/article/manufacturer-experimental-als-treatment-fda-approval/45578505 Manufacturer of experimental ALS treatment withdraws application for FDA approval