This Week at FDA: Eisai wins accelerated approval for Alzheimer’s drug Leqembi

This Week at FDAThis Week at FDA | 06 January 2023 |  By 

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. In major news this week, we saw FDA grant accelerated approval to Eisai's Alzheimer’s disease drug Leqembi (lecanemab-irmb). The agency also moved to enable retail pharmacies to dispense mifepristone by revising the shared risk evaluation and mitigation strategy (REMS) for Mifeprex and generic versions of the drug.
On Friday, FDA granted accelerated approval to Leqembi, which joins Biogen’s Aduhelm as the second drug approved to treat Alzheimer’s disease in recent years based on the surrogate marker of reduction of amyloid plaque in patients taking the drug with mild cognitive impairment or mild dementia.
In an email to members of the press, Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni acknowledged “significant amount of discussion” generated by the agency’s decision to grant accelerated approval to Aduhelm in 2021. She said the decision to approve Leqembi was also based on the same surrogate marker – reduction of amyloid plaque – and stressed that both decisions “were based on rigorous, scientific evaluation of the data contained in their applications and that CDER remains committed to the integrity of our drug approval process.”
Cavazzoni also pushed back on a recent report from the House Energy and Commerce and Oversight and Reform committees that found FDA’s approval process for Aduhelm to be “rife with irregularities.” Cavazzoni said the center “fully cooperated” with the committees’ investigation and emphasized that FDA’s own internal review of CDER’s interactions with Aduhelm’s sponsor were appropriate.
Earlier this week, FDA modified the REMS program for mifepristone to enable the drug to be dispensed by a certified pharmacy that agrees to dispense the product under a prescription by a certified prescriber. The move will enable retail pharmacies to dispense the drug for the first time, according to The New York Times.
In other mifepristone news, Politico reports that FDA denied citizen petitions from the anti-abortion group Students for Life and the American College of Obstetricians and Gynecologists. The former requested the agency limit telemedicine prescriptions for the drug and bring back earlier restrictions from 2011. The latter requested that FDA ease access to the drug for treating miscarriages, which is not one of its currently approved uses.
Politico also reports that some lobbyists are bracing themselves for Sen. Bernie Sanders’ chairmanship of the Senate Health, Education, Labor and Pensions (HELP) Committee. The longtime Senator has been a harsh critic of the pharmaceutical industry and may stand in the way of some of industry’s wish list for the 118th Congress.
Drugs & biologics
FDA announced this week it will convene its group of external experts to discuss allowing the nasal spray version of the drug naloxone hydrochloride, also known as Narcan, on the market without a prescription to treat opioid overdoses. The agency’s Nonprescription Drugs Advisory Committee, and the Anesthetic and Analgesic Drug Products Advisory Committee will meet to discuss the matter on 15 February.
We also learned this week that bluebird bio has sold its second priority review voucher. According to Fierce Pharma, Bristol Myers Squibb purchased the voucher for $95 million.
Over the past few weeks, FDA has published more than a dozen final orders classifying devices and diagnostics as class II products with special controls. A significant number of them are digital health products, and more specifically software as a medical device (SaMD) products, that were originally allowed on the market under the agency’s de novo pathway but now will only require the less burdensome 510(k) application.
This week was also officially the start of FDA’s total product lifecycle advisory program (TAP) that the Center for Devices and Radiological Health (CDRH) has fought hard to include in the recent Medical Device User Fee Amendment (MDUFA V) deal. While the program has been touted by the agency as a significant means for sponsors to get external feedback from stakeholders such as physicians and insurers to prepare their product for market, ultimately, FDA agreed to a soft launch with a pilot program to test the idea over the next five years before it hopes to implement the program fully.
Earlier this week, CDRH announced it has updated its list of recognized medical device consensus standards with more than 60 entries, including one new standard, three revised existing standards, revisions to the extent of recognition to some standards and extended transition periods for two of the standards.


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