Showdown over experimental ALS drug expected before FDA advisers
, the FDA repeated many of its earlier concerns about the drug’s effectiveness, saying additional analyses submitted by the company were flawed and included noNevertheless, ALS advocates hold out hope that the FDA will clear the treatment in the face of intense pressure from patients and their families. About 30,000 people in the United States have ALS, sometimes called “Lou Gehrig’s disease.” Another 6,000 are diagnosed every year.
“We don’t want the FDA to approve just anything, we don’t want to drink bleach,” said Brian Wallach, a former staffer in the Obama White House who was diagnosed with ALS five years ago at 37. Relying on an aide to “translate” his severely affected speech, he added: “We have done our homework and we know that this drug can help us.”
, she said. In addition, Aduhelm posed significant safety issues and its trials were ended prematurely because of a lack of efficacy, while AMX0035 is considered safe and reached its primary goalThose opposed to approval of AMX0035 now fear the FDA will clear another drug prematurely because of pressure from the ALS community. “Yes, people are suffering,”senior health researcher at Public Citizen, acknowledged. “But it doesn’t make it any better to give them crappy medications.
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Scoop: Jif plant in Kentucky had a history of Salmonella, FDA records showFDA inspectors found that Jif officials had identified Salmonella at their plant in Lexington, Kentucky, a dozen times before a recent outbreak.
Read more »
FDA Approves Durvalumab Plus Chemo for Biliary Tract CancerThe immune checkpoint inhibitor is already approved for use in lung cancer. Now it is also approved for use in combination with chemotherapy for locally advanced or metastatic biliary tract cancer.
Read more »
Florida sues FDA over 'delay' of low-cost drug importationsFlorida has sued federal health officials, accusing them of stalling the state's plan to import lower-cost prescription drugs from Canada
Read more »
The FDA’s mass murder of more than half a million AmericansThe Democrat-controlled House Select Subcommittee on the Coronavirus Crisis has accused us of constantly pressuring then-FDA Commissioner Stephen Hahn and his agency to make the antiviral drug hydroxychloroquine (HCQ) available to outpatients in early treatment use. We, in turn, accuse Mr. Hahn, his successor Janet Woodcock, Anthony Fauci, and the broader FDA bureaucracy, of the mass murder of more than half of million Americans who needlessly perished from the effects of COVID-19 because they were denied early access to HCQ.
Read more »
Your at-home COVID-19 test may not have expired after allSome of the expiration dates were extended as the agency received new data that showed the products still worked, according to the FDA. The tests that the federal government sent to people this year now have a 12-month shelf life.
Read more »
Omicron boosters are the future of COVID vaccines in the USThe FDA and CDC both backed the use of bivalent Omicron boosters from COVID vaccine makers, Pfizer and Moderna. Here's how they considered the safety and efficacy data of the new shots.
Read more »