On 22 August 2024, Eisai and Biogen announced that Leqembi® (lecanemab) has received marketing authorisation from the UK’s MHRA for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease.  The UK is the first country in Europe to authorise Leqembi®.  As with approvals in other jurisdictions, the approval was primarily based on results of the global Phase III Clarity study.

However, in a draft guidance issued on 22 August 2024, the UK’s National Institute for Health and Care Excellence (NICE) states that the benefits of lecanemab are too small to warrant making the drug available on the NHS.

Leqembi® has previously been approved for MCI and mild dementia due to Alzheimer’s disease in the US, Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in the European Union, Australia, Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland.

Eisai and Biogen have announced that Leqembi® (lecanemab) has been approved for the treatment of Alzheimer’s disease in the United Arab Emirates. The approval is based on results from the global Phase III Clarity study and will allow treatment of patients with mild cognitive impairment (MCI) or at the mild dementia stage of the disease with Leqembi® (aligning with the patient population targeted in clinical trials).

Leqembi® has previously been approved for the same indication in the US, Japan, China, South Korea, Hong Kong and Israel, and applications are under review in the European Union, Australia, Brazil, Canada, Great Britain, India, Russia, Taiwan, Singapore, and Switzerland.

On 10 June 2024, Eisai and Biogen announced that the FDA accepted Eisai’s sBLA for Leqembi® for monthly intravenous maintenance dosing in treating early Alzheimer’s disease.

On 30 July 2024, Biogen and Eisai announced results from their open label extension study of Leqembi® (lecanemab) in early Alzheimer’s Disease.  The data reportedly shows that three years of continuous treatment with lecanemab reduced clinical decline, demonstrating a continued clinically and personally meaningful benefit for early-stage Alzheimer’s Disease patients.  Biogen and Eisai further report that dual-acting lecanemab is the only widely available early-stage treatment for Alzheimer’s Disease that supports neuronal function by clearing the highly toxic protofibrils that continue to cause neuronal injury and death even after plaques have been cleared from the brain.

This follows the CHMP’s recommendation against granting marketing authorisation for Eisai’s Leqembi® (lecanemab) for Alzheimer’s disease on the basis that the observed effect of Leqembi® on delaying cognitive decline does not counterbalance the risk of serious side effects.  Eisai has indicated it intends to seek review of that decision.

At its July 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Coherus/TMC Pharma’s Loqtorzi® (toripalimab) for nasopharyngeal carcinoma and oesophageal squamous cell carcinoma.  The CHMP also recommended granting marketing authorisation for Astella Pharma’s Vyloy™ (zolbetuximab) for gastric or gastro-oesophageal junction adenocarcinoma.  

Indication extensions were recommended for the following biologics: 

• MSD’s Keytruda® (pembrolizumab), in combination with enfortumab vedotin, for first-line treatment of unresectable or metastatic urothelial carcinoma. 

• Astella Pharma’s Padcev™ (enfortumab vedotin), in combination with pembrolizumab, for first-line treatment of unresectable or metastatic urothelial cancer in adults eligible for platinum-containing chemotherapy. 

• Janssen’s Rybrevant® (amivantamab), in combination with carboplatin and pemetrexed for adults with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI). 

• Boehringer Ingelheim’s Spevigo® (spesolimab), for generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age as monotherapy. 

• Roche’s Tecentriq® (atezolizumab), as monotherapy for first-line treatment of adults with advanced NSCLC who are ineligible for platinum-based therapy. 

The CHMP recommended against granting marketing authorisation for Eisai’s Leqembi® (lecanemab) for Alzheimer’s disease on the basis that the observed effect of Leqembi® on delaying cognitive decline does not counterbalance the risk of serious side effects.  Eisai has indicated it intends to seek review of the decision. 

Leqembi® is approved for treating Alzheimer’s disease in patients with mild cognitive impairment or mild dementia in the US, Japan, China, and South Korea, Hong Kong and Israel, and applications are under review in Australia, Brazil, Canada, Great Britain, India, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland. 

Six biosimilars received positive opinions at CHMP’s July 2024 meeting, as reported here.

On 11 and 12 July 2024, respectively, Eisai and Biogen announced that Leqembi™ (lecanemab) has been approved in Hong Kong and Israel for treating Alzheimer’s disease in patients with mild cognitive impairment or at the mild dementia stage of the disease.

Leqembi® has previously been approved for the same indication in the US, Japan, China, and South Korea, and applications are under review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.

On 10 June 2024, Eisai and Biogen announced that the FDA accepted Eisai’s sBLA for Leqembi® for monthly intravenous maintenance dosing in treating early Alzheimer’s disease.

On 10 June 2024, Eisai and Biogen announced that the FDA has accepted Eisai’s Supplemental Biologics License Application (sBLA) for Leqembi® (lecanemab-irmb) for monthly intravenous maintenance dosing in treating early Alzheimer’s disease.  The target PDUFA action date is 25 January 2025.  

Biogen reports that Leqembi® is approved for treating Alzheimer’s disease in patients with mild cognitive impairment or mild dementia in the US, Japan, China, and South Korea, and applications are under review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.  

On 27 May 2024,  Eisai and Biogen announced that South Korea’s Ministry of Food and Drug Safety approved Leqembi® (lecanemab) for treating adults with mild cognitive impairment or mild Alzheimer’s disease.   

Leqembi® is reportedly the first approved treatment to reduce disease progression and slow cognitive and functional decline in patients with Alzheimer’s disease.  South Korea is the fourth country to approve Leqembi®, following the US in July/2023, Japan in September/2023, and China in January/2024. 

On 3 April 2024, Australia’s PBAC published the July 2024 Meeting Agenda.  On the list of drugs seeking to be PBS reimbursed is Sandoz’s high concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab).  Hyrimoz® is currently PBS-listed in a 40mg/0.8mL form and reimbursement is now being sought for 20mg/0.2mL, 40mg/0.4ml and 80mg/0.8ml forms.

Sandoz launched its high concentration formulation of Hyrimoz® in Europe in November 2023 and in the US in July 2023.

Also on the PBAC July Agenda are applications for new PBS-listings of:

• Eisai’s Leqembi® (lecanemab) for the treatment of early Alzheimer’s disease and Pfizer’s multiple myeloma treatment Elrexfio® (elranatamab), which are each yet to be TGA-approved; and
• Sanofi’s Beyfortux® (nirsevimab) for the prevention of respiratory syncytial virus in babies, approved by the TGA in November 2023.

Roche has applied to PBS-list a new indication (retinal vein occlusion) and new PFS form of its Vabysmo® (faricimab).

BMS is seeking to vary the existing listings for nivolumab and ipilimumab, and Takeda is seeking authority script listing for vedolizumab for continuing treatment of chronic pouchitis.

The reimbursement of Novo Nordisk’s PBS listed Ozempic® (semaglutide) (and other GLP-1 analogues) for the treatment of type 2 diabetes mellitus will also be considered.

Biogen announced it will reprioritise resources allocated to Aduhelm® (aducanumab) to advance Leqembi® (lecanemab) to “develop new treatment modalities”.  Biogen will discontinue development and commercialisation of Aduhelm® 100 mg/mL IV injection and will terminate the current clinical study.

On 22 April 2022, Biogen withdrew its EU MAA for aducanumab following feedback from the CHMP.

Eisai announced that the Scientific Advisory Group (SAG) will meet to discuss Eisai’s marketing authorisation application (MAA) for Leqembi® (lecanemab) which is under review by the European Medicines Agency (EMA).  The SAG is expected to meet before 31 March 2024.  The SAG is being convened at the request of the Committee for Medicinal Products for Human Use (CHMP) of the EMA to provide independent advice on scientific or technical matters relating to products under evaluation.

On 9 January 2024, the Chinese NMPA approved Leqembi® as a treatment for mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia.