Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
| Topics | Advisory Committee |
Date | Details | Biomedtracker Likelihood Of Approval 1 |
|
Amylyx Pharmaceuticals' sodium phenylbutyrate/taurursodiol (AMX0035) for treatment of amyotrophic lateral sclerosis |
Peripheral and Central Nervous System Drugs |
March 30 (teleconference) |
(Also see "Amylyx’s ALS Drug Should Wait For Phase III Results, US FDA Panel Says" - Pink Sheet, 30 Mar, 2022.) |
86%2 |
|
Considerations for use of COVID-19 vaccine booster doses and the process for vaccine strain selection to address current and emerging variants |
Vaccines and Related Biological Products |
April 6 (teleconference) |
N/A |
|
|
Appropriate approach for phosphatidylinositol-3-kinase inhibitors currently under development in patients with hematologic malignancies and whether randomized data should be required to support a demonstration of substantial evidence of effectiveness and that the drug is safe for its intended use in the proposed population |
Oncologic Drugs |
April 21 (teleconference) |
N/A | |
|
TG Therapeutics' sBLA for Ukoniq (umbralisib) tablets and BLA for ublituximab injection for combination treatment of adults with chronic lymphocytic leukemia or small cell lymphocytic lymphoma; committee will also discuss the existing umbralisib accelerated approval indications for relapsed or refractory follicular lymphoma and marginal zone lymphoma |
Oncologic Drugs |
April 22 (teleconference) |
(Also see "TG Therapeutics Ukoniq’s Future In Doubt Amidst Scrutiny Of P13K Inhibitor Accelerated Approvals" - Pink Sheet, 3 Feb, 2022.) |
99% |
|
1 Biomedtracker LOA as of 31 March 2022 2 LOA lowered from 95% based on results of advisory committee meeting |
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