This Week at FDA: FDA approves first FMT product, upcoming mpox guidance, and more

This Week at FDAThis Week at FDA | 02 December 2022 |  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. This week, we saw FDA approve the first fecal microbiota product, halt the emergency authorization of a COVID-19 antibody and advance guidance on the development of treatments for mpox.
This week, FDA approved Ferring Pharmaceuticals’ Rebyota (fecal microbiota, live-jslm) to prevent the recurrence of Clostridioides difficile infection (CDI), marking the first ever approval of a fecal microbiota product. “Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening. As the first FDA-approved fecal microbiota product, today’s action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” said Center for Biologics Evaluation and Research (CBER) Director Peter Marks.
With Omicron subvariants BQ.1 and BQ.1.1 accounting for most COVID-19 cases, FDA has pulled Eli Lilly’s emergency use authorization (EUA) for its antibody treatment bebtelovimab in all US regions, as “it is not expected to neutralize” either subvariant. The agency said that Lilly and its distributors have halted distribution of the drug, though it recommends existing product be retained “in the event that SARS-CoV-2 variants susceptible to bebtelovimab … become more prevalent in the future.”
The Office of Management and Budget (OMB) announced this week that it is reviewing a draft guidance from FDA on developing new drugs and biologics to treat mpox (also known as monkeypox) amid the response to an outbreak of the disease that began earlier this year.
The Wall Street Journal reported this week that FDA is preparing to ease its rules on blood donor deferrals to enable gay and bisexual men in monogamous partnerships to donate blood more readily. The agency’s current guidelines require men who have sex with men to defer from donating blood if they have had sex with another man within the past three months; prior to the COVID-19 pandemic, the deferral period was 12 months.
Drugs & biologics
Amid heightened scrutiny of FDA’s accelerated approval program, Roche has withdrawn its bladder cancer indication for its drug Tecentriq (atezolizumab) at FDA’s request. In 2021, Roche withdrew two indications for Tecentriq in combination with Abraxane (paclitaxel); one in triple-negative breast cancer and another in second-line bladder cancer.
The agency issued a complete response letter (CRL) to Y-mAbs Therapeutics for its investigational neuroblastoma therapy omburtamab. The agency recommended that Y-mAbs come in for a meeting “to discuss adequate and well-controlled trial design to demonstrate substantial evidence of effectiveness and a favorable benefit-risk profile.” The company said it still evaluating the implications of the letter.
FDA also approved CLS Behring’s Hemgenix (etranacogene dezaparvovec) as the first gene therapy to treat adults with hemophilia B. “Today’s approval provides a new treatment option for patients with Hemophilia B and represents important progress in the development of innovative therapies for those experiencing a high burden of disease associated with this form of hemophilia,” said Marks.
In other approval news, FDA okayed Rigel Pharma’s Rezlidhia (olutasidenib) to treat adults with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-1 (IDH1) mutation.
Plus, we learned that bluebird bio has sold one of its two priority review vouchers (PRVs) to Argenx for $102 million. Bluebird bio received vouchers for its under FDA’s rare pediatric disease PRV program upon approval of its gene therapies Zynteglo (betibeglogene autotemcel) and Skysona (elivaldogene autotemcel) earlier this year. Argenx said it plans to use the voucher to speed the review of its experimental neonatal Fc receptor blocker efgartigimod.
The Office of Management and Budget has cleared FDA’s upcoming guidance on homeopathic drug products for release, though the agency issued a revised draft guidance on homeopathic product labeling in 2019.
Reuters reported on Thursday that Gregory Conigliaro, the co-owner of the New England Compounding Center – the compounding pharmacy linked to a deadly meningitis outbreak in 2012 – has been sentenced to one year in prison.
FDA’s Office of Pharmaceutical Quality this week issued several revised manual of policies and procedures (MAPPs): Naming of Drug Products Containing Salt Drug Substances, Office of Biotechnology Products and Office of Pharmaceutical Manufacturing Assessment, Interactions on BLA Assessments, Acceptance Criteria for Residual Solvents, and Process for Evaluating Emerging Technologies Related to Quality.
Several top US senators are urging President Joe Biden to address the ongoing shortage of amoxicillin. Sens. Amy Klobuchar (D-MN), Bill Cassidy (R-LA), Sherrod Brown (D-OH), and Ed Markey (D-MA) noted that the shortage of the widely used antibiotic could have serious consequences for patients by delaying care.
This week FDA announced it recognized a new Medical Device Development Tool (MDDT) – the CHemical RISk calculator (CHRIS) – color additives. The agency said that researchers can CHRIS to evaluate potential biocompatibility risks associated with color additives. The tool is a Nonclinical Assessment Model (NAM) that sponsors can refer to in their premarket applications for screening level risk assessments when evaluating the biocompatibility of polymeric medical device components that contain color additives.
The agency also announced a shortage of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including limited supplies of IAB catheters, new Cardiosave IABPs, and Cardiosave IABP parts. It advised stakeholders to read Getinge’s letter on the device shortage, which provides instructions on temporary maintenance updates for Cardiosave IABP Safety Disk and Lithium-Ion Battery. The agency also asked stakeholders with extra devices to share their inventory and for those with any issues with their devices to report them to FDA.
Next week FDA is holding a three-day virtual Digital Transformation Symposium on 5 December where the agency plans to talk about its plans for IT modernization; how it is using data, cloud services and cybersecurity to further its mission; and plans to engage stakeholders on what more it can do to promote innovation. The meeting will be kicked off by Vid Desai, FDA chief information officer, and FDA commissioner Robert Califf and Janet Woodcock, FDA principal deputy commissioner.


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