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AbbVie Remains Confident About Rinvoq Despite Coming Safety Labeling Update

 
• By Joseph Haas

A safety-related FDA revision of Rinvoq’s label in rheumatoid arthritis is a perceived threat to the JAK inhibitor’s growth, but it and fellow immunology asset Skyrizi produced another strong sales quarter.

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AbbVie remains optimistic about Rinvoq growth despite pending FDA label revision

The US Food and Drug Administration’s September drug safety communication on cardiovascular and cancer risks posed by the Janus kinase inhibitor class of drugs means thatAbbVie Inc.’s oral rheumatoid arthritis therapy Rinvoq (upadacitinib) soon will get a revised label, but the pharma’s top execs expressed confidence about growth projections for the JAK inhibitor during a 29 October sales and earnings call, even if the safety update is restrictive.

In its 1 September announcement that Pfizer Inc

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Takeda Plans US Investment But Sees Little Impact From Tariffs

 
• By Alaric DeArment

The Japanese drug maker is on track for three pivotal Phase III readouts and two regulatory submissions in 2025.

Q1 S&E In Brief: Tracking New Launches And Catalysts In Biopharma

 
• By Jessica Merrill and Joseph Haas

Neurocrine, Madrigal and Vanda updated investors on new drug launches, while Cytokinetics talked to investors about an FDA extension for aficamten.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

Sarepta Slammed By Double Blow: Elevidys Sales Miss, Prasad’s CBER Appointment

 
• By Mandy Jackson

Sarepta’s stock price was battered after Vinay Prasad was appointed to lead the US FDA’s CBER, then the company’s shares were bruised when Q1 Elevidys sales came in below consensus.

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Finance Watch: Deerfield Closes $600m-Plus VC Fund; Gates Speeds Up Health Investments

 
• By Mandy Jackson

Private Company Edition: Deerfield’s third innovations fund will back therapeutics and other opportunities, the Gates Foundation – a sometimes funder of biotech firms – will spend $200bn over the next 20 years, and NewLimit raised a $130m series B round, among other financings.

Pharma Left Hanging After US/UK Trade Pact

 
• By Kevin Grogan

An ‘historic economic prosperity deal’ does not include the sector.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.