1. Scrip
  2. >>New Products

Regeneron's Less Frequent Eylea Dosing Makes Late Sprint Across FDA Finish Line

 
• By Mandy Jackson

Regeneron's blockbuster AMD biologic Eylea improved its ability to compete with future longer-acting VEGF inhibitors with a label supporting every dosing every 12 weeks; the company's less frequent regimen cleared FDA five days after receiving a complete response letter.

Red Approved Stamp with Wooden handle Rubber Stamper Isolated on White Background.

US FDA’s Aug. 17 approval of a supplemental biologic license application for Eylea (aflibercept) keeps Regeneron Pharmaceuticals Inc. well ahead of competitors developing treatments for wet age-related macular degeneration (AMD) that can be given less often, a significant advantage for products that are injected into the eye.

The sBLA for Eylea dosed every 12 weeks was approved just four days after the company said it received a complete response letter for the application.

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

Sanofi Bid For Second COPD Approval Hurt By Mixed Itepekimab Data

 
• By Kevin Grogan

One Phase III trial hits but a second study misses by a mile.

Bayer Has BI In Its Sights With Priority Review For HER2 Lung Cancer Drug

 
• By Kevin Grogan

Sevabertinib gets onto the FDA's approval fast track three months after zongertinib.

Pipeline Watch: 12 Approvals And 26 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.

Boehringer’s CMO On How AI, Integrated Evidence Generation Underpin Its Ambitious Launch Plans

 
• By Alexandra Shimmings

The German company has big plans for the next five years or so. Scrip speaks to its chief medical officer Lykke Hinsch Gylvin about how it is using AI and other innovative approaches to make good on its ambitions.

More from Scrip

Merck & Co./Daiichi Pull Patritumab Deruxtecan BLA On Disappointing OS

 
• By Jessica Merrill

Patritumab deruxtecan is the lead antibody drug conjugate in a $22bn deal signed between the two partners, with the decision marking a disappointing setback

Executives On The Move: Innate Pharma And Alloy Therapeutics Get New CEOs

Pascal Soriot, CEO of AstraZeneca, joins Agilent Technologies' board, plus Zealand Pharma acquires chief development officer from UCB Biopharma.

Senti’s Computer-Logic Inspired Cell Therapy Shows Early Promise

 
• By Andrew McConaghie

The biotech believes its logic-gated cell therapies can get round the need for ‘clean targets’ which limit CAR-Ts and ADCs.