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Rexulti On Track To Add Claim For Alzheimer’s Dementia Agitation Following US Panel Nod

 
• By Sue Sutter

Nine of 10 advisory committee members voted favorably for an expansion of brexpiprazole’s label, but some said Otsuka/Lundbeck’s atypical antipsychotic may not be appropriate first-line treatment for patients with mild symptoms or for use in individuals with acute, severe agitation.

Path in forest
Rexulti is on a path to becoming the first FDA-approved treatment for agitation associated with Alzheimer's dementia. • Source: Shutterstock

Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S’ atypical antipsychotic Rexulti (brexpiprazole) has a favorable benefit-risk profile for treatment of agitation associated with Alzheimer’s dementia, but it may not be appropriate for patients with mild symptoms or those with severe, acute agitation, members of a US Food and Drug Administration advisory committee said on 14 April.

Nine of 10 members of the Psychopharmacologic Drugs and Peripheral and Central Nervous System Drugs advisory committees voted favorably for...

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America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
• By Bridget Silverman

In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.

Global Pharma Guidance Tracker - April 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.