Daily Briefing

Around the nation: FDA committee voices partial support for new ALS drug


FDA advisors on Wednesday signaled partial support to expedite the approval of Biogen's experimental drug aimed at a rare form of ALS, in today's bite-sized hospital and health industry news from Maryland, North Carolina, and Wyoming.

  • Maryland: FDA's Peripheral and Central Nervous System Drug Advisory Committee on Wednesday signaled partial support to expedite the approval of Biogen's experimental drug aimed at a rare form of ALS. In a 9-0 vote, the committee agreed that reduction of a protein biomarker in patients treated with the drug, called tofersen, likely predicts a clinical benefit. However, the panel later voted 5-3 — with one abstention — that clinical data from the placebo-controlled study and other results did not provide sufficient evidence of the drug's effectiveness. Currently, there are no approved therapies for the genetic form of ALS — a progressive neurological disease that typically kills patients within three to five years of onset. However, tofersen did not achieve the primary goal of a late-stage trial last year and has a risk of serious side effects. FDA staff earlier this week said the committee's concerns should not prevent expedited approval, citing "regulatory flexibility" to accelerate access to new treatments for patients with life-threatening conditions who have no alternative. The agency will consider the committee's recommendations and make a final decision next month. (Bettelheim, Axios, 3/23)
  • North Carolina: The North Carolina General Assembly on Wednesday advanced a bill that would expand Medicaid in the state. The bill, which cleared the Senate in a 44-2 vote last week and passed the House in 94-22 vote on Wednesday, garnered the support of all General Assembly Democrats and almost all Republicans. The House on Thursday held a final confirming vote to complete the legislative process, with the resulting tally being 87-24 in support of the legislation. Gov. Roy Cooper (D) is expected to sign the bill. The bill includes new assessments on hospitals to finance the state's share of the expansion's costs, which are estimated to total around $550 million a year. In addition, the bill would relax certificate of needs laws. The North Carolina Healthcare Association, which represents hospitals, has endorsed the proposal. "Medicaid expansion is the single most transformative state policy the N.C. General Assembly can enact to increase access to healthcare and strengthen the primary care safety net," North Carolina Community Health Center Association president and CEO Chris Shank said. (Nzanga, Modern Healthcare, 3/22; AP/ABC News, 3/23)
  • Wyoming: U.S. District Court Judge Melissa Owens on Wednesday temporarily blocked a statewide abortion ban due to a lawsuit that challenges the state's law banning abortion at all stages of pregnancy in most cases, and another law set to take effect in July that bans abortion pills. Under the law that went into effect Sunday, abortions are a felony punishable by up to five years in prison. According to the law, "abortion defined in this act is not healthcare." Abortion rights groups claim that this measure violates the state's constitution, which gives adults the right to make their own healthcare decisions. "The state cannot legislate away a constitutional right," Owens said. "It's not clear whether abortion is health care. The court has to then decide that," she added. "Now, the medication abortion ban and the overall ban will be considered at a hearing where the plaintiffs will seek an injunction to suspend both laws until the full lawsuit can be heard," the New York Times reports. (Falconer, Axios, 3/23)

 


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