Leqembi Approval Opens Door To Alzheimer’s Market For Lilly And Others

Pointers On Competition Expected From Lilly’s Full Phase III Data

Full approval for Leqembi is not only a breakthrough for Eisai and Biogen, it will also give companies and investors greater confidence in investing in more novel Alzheimer’s therapies.

Alzheimer's jigsaw

The full approval of Eisai and Biogen’s Leqembi (lecanemab) by the US Food and Drug Administration on 6 July is a milestone for the Alzheimer’s treatment market, and helps create a regulatory and market access pathways for late-stage candidates and future drugs.

Leqembi gained accelerated approval in January, but this was converted to a full approval by the US regulator based on the Phase III Clarity AD study, which showed that 18 months of treatment of Leqembi saw patients’ condition decline 27% less than those in the placebo group

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 Clinical Trials

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By 

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.

In Brief: Strong OS Results For Immutep’s Eftilagimod/Keytruda Combo In Head And Neck Cancer

 

Australian firm's combo of eftilagimod and Keytruda shows 17.6-month median overall survival in first-line HNSCC patients with low PD-L1, raising hopes for potential accelerated approval.

In Brief: Positive New Data For Aptose’s Triplet Therapy In 1L AML

 

Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.

More from R&D

Chinese Firms Build Obesity Clinical Pipeline But Face Wider Hurdles

 
• By 

Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.

Aldeyra Plans To File Reproxalap Again With New Dry Eye Symptom Data

 
• By 

The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.

Lilly And Alchemab Tap Into Resilient Individuals To Develop ALS Drug

 

The pharma company is helping to validate the biotech’s model by developing a novel amyotrophic lateral sclerosis candidate, based on its novel approach that ‘turns drug discovery on its head’.