1. Scrip
  2. >>New Products

AbbVie Expected To Ditch Abicipar After US FDA Setback

 
• By Joseph Haas

With a complete response letter for wet AMD drug abicipar, AbbVie is expected to move on from the drug acquired with Allergan. Molecular Partners now seems inclined to focus on IO, virology.

Female eye with long eyelashes close up. Closeup shot of female gray - blue colour eye with day makeup. Beauty female eye with curl long eyelashes
FDA determined that abicipar's benefit don't outweigh its risk of intraocular inflammation

AbbVie Inc. seems unlikely to invest further resources or effort into anti-VEGF drug abicipar pegol for wet age-related macular degeneration (AMD) following a US Food and Drug Administration complete response letter on 26 June, and Molecular Partners AG, which discovered and initially developed the candidate, also appears to be positioning away from ophthalmology to increase its focus on cancer and virology programs.

Both companies announced the CRL on 26 June, noting that the FDA decided the drug has an unfavorable benefit-risk ratio...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from New Products

Pipeline Watch: Ten Approvals And Seventeen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Defying Gravity: Five Drugs That Surpassed Their Sales Forecasts

 
• By Edwin Elmhirst

Many assets outperform their pre-launch sales predictions despite the frequent overestimation of forecasts within the industry. In this article, Scrip highlights several such assets and the factors that influenced their predictions.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 
• By Alexandra Shimmings

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

What Incyte Investors Expect From New CEO Bill Meury

 
• By Andrew McConaghie

Fresh from having sold Anthos to Novartis, the new CEO is expected to update the oncology and dermatology-focused firm's strategy.

Bayer Buoyant After EU Nod For Twice-Yearly Eylea

 
• By Kevin Grogan

Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.

Executives On The Move: New CEO At Atalanta Therapeutics

Recent moves in the industry include C-suite changes at Atalanta Therapeutics and Climb Bio, plus seven companies get new CMOs.