Federal health advisors voted 17-1 against an experimental treatment for Lou Gehrig's disease dubbed NurOwn, although the FDA is not bound by the vote.
at a Wednesday meeting prompted by years of patient efforts seeking access to the unproven therapy.
While the FDA is not bound by the vote, it largely aligns with the agency's own strikingly negative review released earlier this week, in which staff scientists described Brainstorm's application as"scientifically incomplete" and"grossly deficient.
Brainstorm's single 200-patient study failed to show that NurOwn extended life, slowed disease or improved patient mobility. But FDA agreed to convene the panel of outside advisers after ALS patients and advocates submitted a 30,000-signature petition seeking a public meeting. FDA leaders have recently emphasized a new level of"regulatory flexibility" when reviewing experimental treatments for fatal, hard-to-treat conditions, But the agency appears unwilling to overlook the failed study results and missing information in Brainstorm's submission, including key details on manufacturing and quality control needed to establish the product's safety.
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