FDA Roundup: Advisers Reject MDMA, Recommend New COVID-19 Vaccines

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Check out important updates from the FDA for the week of June 3.

FDA Advisory Panel Votes Against MDMA-Assisted Therapy for PTSD

FDA Roundup: Advisers Reject MDMA, Recommend New COVID-19 Vaccines / grandbrothers - stock.adobe.com

FDA Roundup: Advisers Reject MDMA, Recommend New COVID-19 Vaccines / grandbrothers - stock.adobe.com

An independent FDA advisory panel voted against the use of midomafetamine (MDMA)-assisted therapy to treat post-traumatic stress disorder (PTSD) during a meeting held Tuesday. The Psychopharmacologic Drugs Advisory Committee, which met to discuss the new drug application (NDA) from Lykos Therapeutics, voted 9-2 that MDMA-assisted therapy to treat PTSD is not effective and 10-1 that the benefits of the treatment do not outweigh its risks.

Much of the meeting’s discussion centered around 2 phase 3 clinical trials conducted by Lykos: MAPP1 (NCT03537014) and MAPP2 (NCT04077437). Members of the panel raised concerns about the occurrence of functional unblinding in the studies, as well as adverse events that occurred, particularly around cardiovascular effects from the drug. Committee members also cited the lack of data on the potential for abuse as a major issue.

The advisory panel meeting was the first to review a psychedelic-assisted therapy in the United States. Although the FDA does not have to follow the committee’s vote, the federal agency does usually base its decision on it. If approved, the NDA from Lykos—which was assigned a Prescription Drug User Fee Act (PDUFA) date of August 11, 2024—would be the first MDMA-assisted therapy and first psychedelic-assisted therapy in the country.

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FDA Advisory Panel Recommends New COVID-19 Vaccines

The FDA’s vaccines and related biological products advisory committee unanimously voted during a meeting to recommend new COVID-19 vaccines that target the JN.1 variant for the upcoming fall season. According to the New York Times, there are 3 vaccine producers who will make vaccines available: mRNA versions from Pfizer and Moderna, and a protein-based vaccine from Novavax.1

In a press release, Novavax said that the advisory panel “acknowledged the advantages of a JN.1 vaccine in providing broad protection against circulating and future strains, based upon data presented by all manufacturers, and the need to minimize confusion in making public health recommendations.”2 Data from the Infectious Disease Society show that the Omicron variants JN.1 and JN.1 descendants KP.2 and KP.3 are highly prevalent in the United States, accounting for nearly 30% of new COVID-19 cases in the country.3

FDA Approves Imetelstat to Treat Lower Risk Myelodysplastic Syndromes

The FDA approved imetelstat (Rytelo) for the treatment of low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent (TD) anemia in adult patients requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA), Geron announced in a release.4

The approval was based on data from the Merge Phase 3 clinical trial, in which imetelstat met both its primary and key secondary endpoints. In the trial, patients treated with imetelstat had significantly higher rates of red blood cell transfusion independence for at least 8 consecutive weeks and for at least 24 weeks. The safety of imetelstat was seen to be generally manageable, with short-lived thrombocytopenia and neutropenia.

“For patients with lower-risk MDS and anemia who are transfusion dependent, we have very few options today and often cycle through available therapies, making the approval of RYTELO potentially practice changing for us,” Rami Komrokji, MD, Vice Chair of the Malignant Hematology Department at the Moffitt Cancer Center, said in a release.4 “What is exciting about Rytelo is the totality of the clinical benefit across LR-MDS patients irrespective of ring sideroblast status or high transfusion burden, including sustained and durable transfusion independence and increases in hemoglobin levels, all within a well-characterized safety profile of generally manageable cytopenias.”

READ MORE: FDA Updates Resource Center

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References
1. Weiland N, Jewett C. F.D.A. Advisers Recommend a New Covid Vaccine Formula for the Fall. News Report. New York Times. June 5, 2024. Accessed June 7, 2024. https://www.nytimes.com/2024/06/05/health/covid-vaccine-autumn.html
2. Novavax Prepared to Deliver JN.1 Protein-based Non-mRNA COVID-19 Vaccine This Fall Consistent with U.S. FDA VRBPAC Recommendation. News Release. Novavax. June 5, 2024. Accessed June 7, 2024. https://ir.novavax.com/press-releases/Novavax-Prepared-to-Deliver-JN-1-Protein-based-Non-mRNA-COVID-19-Vaccine-This-Fall-Consistent-with-U-S-FDA-VRBPAC-Recommendation
3. COVID-19 Variant Update. Report. IDSA. June 5, 2024. Accessed June 7, 2024. https://www.idsociety.org/covid-19-real-time-learning-network/diagnostics/covid-19-variant-update#/+/0/publishedDate_na_dt/desc/
4. Geron Announces FDA Approval of RYTELO™ (imetelstat), a First-in-Class Telomerase Inhibitor, for the Treatment of Adult Patients with Lower-Risk MDS with Transfusion-Dependent Anemia. News Release. Geron. June 6, 2024. Accessed June 7, 2024. https://ir.geron.com/investors/press-releases/press-release-details/2024/Geron-Announces-FDA-Approval-of-RYTELO-imetelstat-a-First-in-Class-Telomerase-Inhibitor-for-the-Treatment-of-Adult-Patients-with-Lower-Risk-MDS-with-Transfusion-Dependent-Anemia/default.aspx
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