New ALS drug, Patients and advocates are celebrating the approval of a new treatment designed to slow the progression of ALS, a devastating neurogenerative disease that kills most people within five years. The drug, Relyvrio, is only the third ALS treatment cleared by the Food and Drug Administration in almost three decades and the first since 2017.
Brian Wallach, a former Obama administration official who founded the nonprofit group I AM ALS after being diagnosed with the disease, tweeted that the approval has provided “something that is really rare for us; real, tangible hope.” But the FDA action also stirred controversy. Some people — including FDA staff and some of the agency’s own outside advisers — raised concerns about the clinical trial for the drug, saying it had flaws and that the data was not strong enough to warrant an approval. The new therapy is far from a cure. new ALS drug, The powdered concoction, which is mixed with water and swallowed or taken through a feeding tube, is designed to slow the disease by protecting nerve cells in the brain and spinal cord destroyed by ALS. In a 24-week study, 137 patients were randomized to receive Relyvrio or a placebo. The people in the treatment group experienced a 25 percent slower rate of decline in performing activities such as walking, talking and cutting food compared with those receiving a placebo. The data and subsequent analyses also indicated those patients lived several months longer. The Cambridge, Mass., company set a list price of $158,000 a year for the first year a patient is on the drug, increasing to $163,000 annually thereafter when the patient is on a full dose. That’s not what most people will pay, however.
For people with private insurance, Amylyx officials said, the company will provide financial assistance to eliminate co-payments. They also said the drug would be made available without charge to uninsured patients who meet eligibility criteria. And the company is exploring ways to keep down out-of-pocket costs for patients with government coverage such as Medicare and Medicaid. Calaneet Balas, president and CEO of the ALS Association, said her organization is working to help secure insurance coverage from officials at Medicare, the Department of Veterans Affairs, commercial plans and other payers. “We expect all payers to cover this and any drug approved for people living with ALS,” Balas said in an email. new ALS drug, The price drew criticism from some advocates. A few weeks ago, the Institute for Clinical and Economic Review, a nonprofit group that analyzes evidence on the effectiveness and value of drugs, said a fair price would be $9,100 to $30,600 annually.
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