FDA accelerates approval of drug for amyotrophic lateral sclerosis (ALS); hundreds of thousands could lose Medicaid coverage under Republican debt bill including work requirements; the Department of Veterans Affairs (VA) reports that half a million veterans have filed claims for health benefits related to toxic exposures.
The FDA has granted accelerated approval to Biogen's injectable drug for a rare genetic form of amyotrophic lateral sclerosis (ALS), according to the Associated Press. The drug, tofersen (Qalsody), is the first for an inherited form of ALS that is thought to affect fewer than 500 individuals in the United States. Although Biogen's 100-person study failed to demonstrate significant slowing of the disease compared with a placebo, the FDA said the findings were "reasonably likely to predict a clinical benefit in patients." Biogen must continue studying tofersen in a trial of individuals with the genetic mutation but not yet showing symptoms.
The Congressional Budget Office estimates that 600,000 people would lose Medicaid coverage under the House Republican debt bill, which would impose work requirements, according to Axios. The proposal would require Medicaid recipients to work 80 hours a month and would save the federal government $109 billion over a decade. However, opponents argue that even those who comply with the requirement could still lose coverage due to burdensome reporting processes, and the Biden administration estimates that 21 million people subject to the work requirement are at risk of losing coverage.
The Department of Veterans Affairs (VA) has reported that half a million veterans have filed claims for benefits related to toxic exposures while serving, according to The Wall Street Journal. The PACT Act, passed last summer, gave veterans access to benefits and health care coverage after exposure to burn pits, radioactive material, herbicides, and other toxins. The VA has awarded more than $1 billion in benefits to veterans and survivors who filed PACT Act–related claims, with the agency also screening 3 million veterans for toxic exposure.
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