1. Scrip
  2. >>Business
  3. >>Strategy

Lilly Settles On Rolling Submission For Tirzepatide In Obesity

 
• By Joseph Haas

Plan for rolling submission means US FDA filing of GIP/GLP1 agonist in obesity could be complete by April 2023, setting up possibility of late 2023 approval.

Accelerated process
Lilly hopes the rolling submission process will acclerate tirzepatide's path to the weight-loss market • Source: Shutterstock

Although Eli Lilly and Company had hoped to file its GIP/GLP-1 agonist tirzepatide to treat adults with obesity or who are overweight based just on data from the Phase III SURMOUNT-1 trial and earlier trials in type 2 diabetes, it is revising its regulatory strategy, presumably based on consultation with the US Food and Drug Administration. The pharma announced on 6 October that it got a fast track designation from the FDA and will make a rolling submission of its new drug application, which could be ready for review when SURMOUNT-2 data are expected in April.

Approved for type 2 diabetes under brand name Mounjaro, tirzepatide is already competing with Novo Nordisk A/S’s drugs in that space, but Lilly also hopes to take on the Danish biopharma’s GLP-1 agonist Wegovy/Ozempic (semaglutide) in the lucrative weight-loss setting. (Also see "Novo’s Wegovy Excels But Lilly Rival Hot On Heels" - Scrip, 29 April, 2022

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 Strategy

A Short History Of MASH Deals, Culminating In GSK/Boston Pharma

 
• By Joseph Haas

Both high-profile failures and small investments that are yielding success so far characterize the dealmaking in MASH over the past 15 years or so.

Lupin CEO On Trump’s Most Favored Nation Policy, Tariffs, Firm’s Five-Year Plan

 
• By Vibha Ravi

Lupin CEO Vinita Gupta speaks on Trump’s Most Favored Nation Policy, the Inflation Reduction Act’s “pill penalty” and other developments in the US, a major market for the company, as she and MD Nilesh Gupta outline a five-year plan focused on complex generics and technology platforms

Novo Nordisk’s CEO Forced Out After Falling Behind In GLP-1 Battle

 
• By Andrew McConaghie

Company surprises investors with Jørgensen's exit but insists its strategy will not change.

Will Other Major MASH Deals Follow GSK/Boston Pharma?

 
• By Joseph Haas

GSK’s $1.2bn payout for Boston Pharma’s efimosfermin is the first billion-dollar-plus MASH deal in nearly nine years, but several other advanced MASH programs could be positioned for takeout.

More from Business

In Brief: US FDA Delay Sends Biohaven Shares Down

 
• By Andrew McConaghie

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

In Brief: Sanofi Commits $20bn To US R&D And Manufacturing By 2030

 
• By Sushmita Panda

Move by French major aligns with broader industry efforts to localize production amid political pressure, as Trump pushes to onshore manufacturing and hints at easing tariff threats.

Eisai Forecasts 73% Leqembi Sales Rise In FY25 As Demand Expands

 
• By Mandy Jackson

Eisai spent most of its FY24 earnings call discussing plans for growing sales of Biogen-partnered Alzheimer’s drug Leqembi from JPY44.3bn ($304.1m) to JPY76.5bn ($525.1m) in FY25.