Latest From Sue Sutter
Janssen’s ponesimod for relapsing multiple sclerosis had a slightly faster review in the US.
In approving ponesimod for relapsing multiple sclerosis, neither the FDA nor EMA included in labeling data from a novel patient-reported outcomes fatigue instrument; FDA said the PRO was not shown to be capable of measuring within-patient change, while EMA said the difference relative to Sanofi’s Aubagio fell short of the threshold for a clinically meaningful benefit.
New maternal/pediatric work group will consider recommendations for use of RSV vaccines and monoclonal antibodies targeting protection of children <18 years. With several products in the late-stage pipeline, group has begun reviewing RSV epidemiology and discussing cost-effectiveness.
Advisory Committee on Immunization Practices’ October vote on use of Pfizer’s Prevnar 20 and Merck & Co’s Vaxneuvance was more restrictive than intended, inadvertently leaving out guidance for people who were previously vaccinated with Prevnar 13.
In the EUA for Pfizer’s COVID-19 oral antiviral treatment, US FDA required a reduced dose for some renally impaired patients that is ‘incongruent with how Paxlovid is packaged,’ meaning that pharmacists have to manually make changes to each blister pack. Prescribers will have to navigate an extensive list of contraindicated medicines due to CYP3A effects.
Merck/Ridgeback’s COVID-19 Drug Molnupiravir Met EUA Bar, But More Data Needed For Full Approval – US FDA
Reviewers believed it was worth making the oral antiviral available for second-line use under the relatively low bar for emergency authorization despite the drug’s significant potential risks, ‘modest benefit’ and ‘unexplained difference’ in efficacy results from the interim and full analysis populations in the pivotal trial.