Lilly Waiting On Phase III Data For Donanemab

Lilly no longer plans to complete an accelerated approval submission for Alzheimer’s candidate donanemab during Q1 following the CMS draft coverage decision for amyloid-targeting therapies.

Alzheimers_677117191_Atthapon-Raksthaput_1200.jpg
Lilly hopes confirmatory Phase III data will change CMS's view on amyloid-lowering drugs

The narrow possibilities for coverage of Alzheimer’s disease therapies under the US Centers for Medicare and Medicaid Services’ current coverage decision has eliminated the need to push for a quick accelerated approval of its Alzheimer’s candidate donanemab, Eli Lilly and Company execs told the firm’s fourth quarter and full year 2021 earnings call on 3 February. Instead, Lilly will wait for Phase III data that could be more convincing for payers, practitioners and regulators.

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

More from Earnings

Novartis Doubles Down On Push For Higher Drug Prices In Europe

 

CEO Vas Narasimhan urged European governments to spend more to support drug innovation during Novartis's first-quarter results call.

BridgeBio Takes A Victory Lap With First Full Quarter Of Attruby Sales

 
• By 

BridgeBio reported $36.7m in Q1 2025 sales of its ATTR-CM drug Attruby, tripling consensus forecasts. Vyndaquel-maker Pfizer acknowledged the product’s impact during the quarter.

GSK Chief Optimistic About BD Despite Volatile Environment

 
• By 

Emma Walmsley tells Scrip that the "biotech market is under a certain degree of pressure," so reasonably priced deals are available.

Pfizer CEO Bourla ‘Cautiously Optimistic’ About Tariffs, Pricing Policies

 
• By 

Bourla said the pharma industry may be able to negotiate productive solutions to Trump tariff and drug pricing concerns. He asserted anti-science views are not shared by all in the administration.

More from Business

Novartis Gains Further Renal Territory With Regulus Acquisition

 

The San Diego biotech’s lead product candidate is an antisense oligonucleotide-based therapy slated to enter Phase III development in the third quarter.

In Brief: Merck To Invest $1bn In New US Biologics Production

 

Merck is investing $ 1bn in a Delaware facility to produce Keytruda and expand biologics manufacturing amid US tariff concerns.

Can European Biotech Survive And Thrive In Era Of Instability?

 

Europe's biopharma sector could suffer if the Trump administration incentivizes US investment but VC leaders believe the region can still thrive and potentially capitalize on instability elsewhere.