Spherix
April 14, 2023
Source: drugdu
133
U.S. neurologists are “cautiously optimistic” about using Eisai’s Leqembi in Alzheimer’s disease as concerns about safety and the need for the FDA’s full green light for the drug remain high barriers to uptake.
That’s according to a new survey and report out by drug launch analyst Spherix Global Insights, which in March asked 73 neurologists working in the U.S. about their use and receptivity of Leqembi, which was partially approved by the FDA at the start of the year.
Now launched, the drug finds itself at a strange junction. It still does not have a full FDA approval; that isn’t set to come until early July. While there is another new drug on the market for Alzheimer’s—namely Aduhelm, which Eisai helped create with Biogen—that drug is commercially dead in the water.
The Centers for Medicare & Medicaid Services (CMS) refused to cover payments of Aduhelm, which was also hit by the controversial way the FDA approved the drug in 2021. The drug passed the regulatory hurdle despite some serious safety and efficacy questions, not least from the FDA’s own drug review experts who denied its approval at the drug’s advisory committee and were overruled by the FDA proper several months later.
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