On 1 April 2025, Eisai reported that the final process for the European Commission (EC) regulatory review of Eisai’s Marketing Authorisation Application (MAA) for Leqembi® (lecanemab) as a treatment for early Alzheimer’s disease (AD) is underway.

In February 2025, Biogen and Eisai announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) reaffirmed its positive opinion for Leqembi® for early Alzheimer’s disease.  The EC has deliberated on the MAA in its Standing Committee and has now referred the decision to the Appeal Committee in accordance with the EC review process.

Leqembi® has 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 Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland.  Australia’s Therapeutic Goods Administration (TGA) declined to approve Leqembi® (lecanemab) for the treatment of early Alzheimer’s Disease.

On 6 March 2025, the UK’s National Institute for Health and Care Excellence (NICE) opened a second consultation period in respect of the use of Eisai/Biogen’s Leqembi® (lecanemab) on the NHS in England for treating mild cognitive impairment (MCI) or mild dementia caused by Alzheimer’s disease.  The consultation follows NICE’s draft guidance in August 2024 determining that the benefits of lecanemab were too small to warrant making the drug available on the NHS for this indication.

The closing date for comments to be provided to the evaluation committee is 27 March 2025.  An evaluation committee meeting is scheduled for 14 May 2025, with publication of the decision expected in July 2025.

The UK was the first country in Europe to authorise Leqembi® in August 2024 for the treatment of MCI or mild dementia due to Alzheimer’s disease.  After NICE’s draft guidance against recommending making the drug available on the NHS for this indication, in February 2025, the Scottish Medicines Consortium (SMC) similarly declined to recommend reimbursement of Leqembi® for treating early-stage Alzheimer’s disease, citing uncertainties surrounding the drug’s clinical benefits and cost-effectiveness.

Leqembi® has 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 Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland.  While Australia’s Therapeutic Goods Administration (TGA) has declined to approve Leqembi® (lecanemab) for the treatment for early Alzheimer’s Disease, in February 2025, the CHMP reaffirmed its positive recommendation for approval of this indication.

On 3 March 2025, Eisai and Biogen announced that Australia’s Therapeutic Goods Administration (TGA) has confirmed its initial decision to decline the approval of Leqembi® (lecanemab) for the treatment of early Alzheimer’s Disease (AD).  Eisai is “extremely disappointed and surprised by the TGA’s decision” and is exploring its options, including the possibility of seeking a review of the TGA’s decision by Australia’s Administrative Review Tribunal.

The TGA issued a decision in October 2024 not to approve Leqembi® for the treatment of patients with mild Alzheimer’s dementia (early Alzheimer’s disease) and mild cognitive impairment (MCI) due to Alzheimer’s disease.  The decision was based on the TGA’s opinion that demonstrated efficacy of the drug did not outweigh the safety risks associated with use of lecanemab.  Eisai subsequently requested reconsideration of the decision.

As part of the reconsideration, the TGA proposed a narrowed therapeutic indication but ultimately no indication could be agreed upon by the TGA and Eisai.

Leqembi® has 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 Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland.  In February 2025, the CHMP reaffirmed its positive recommendation for approval of lecanemab for MCI and mild dementia due to Alzheimer’s disease.

On 28 February 2025, Biogen and Eisai announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion for Leqembi® (lecanemab) for early Alzheimer’s disease.

In late January 2025, the European Commission had asked the CHMP to re-consider the positive opinion granted for Leqembi® in November 2024 following safety information that had since become available.

The CHMP’s reaffirmed recommendation for approval means that the EC will now resume its decision-making process for lecanemab’s marketing authorisation.

The UK was the first country in Europe to authorise Leqembi® in August 2024 for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease.  However, in the same month, the UK’s NICE determined that the benefits of lecanemab were too small to warrant making the drug available on the NHS.  Similarly, earlier in February 2025, the Scottish Medicines Consortium (SMC) declined to recommend reimbursement of Leqembi® for treating early-stage Alzheimer’s disease, citing uncertainties surrounding the drug’s clinical benefits and cost-effectiveness.

On 10 February 2025, the Scottish Medicines Consortium (SMC) issued its February 2025 decisions on medicines for reimbursement by NHS Scotland, including accepting three biologics and rejecting another.

AstraZeneca’s Imfinzi® (durvalumab) will be reimbursed for use in combination with chemotherapy for the treatment of adults with newly diagnosed extensive-stage small cell lung cancer.  This follows recommendation of the combination therapy by UK’s NICE in January 2025.  Regeneron and Sanofi’s Libtayo® (cemiplimab) has also been accepted for reimbursement by the SMC for the treatment of adults with recurrent or metastatic cervical cancer, where the cancer has progressed on or after chemotherapy.

AstraZeneca and MSD’s Lynparza® (olaparib) was accepted for the treatment of adults with BRCA1 or 2 mutated HER2-negative advanced breast cancer, who have already received appropriate treatments for their type of breast cancer.  In December 2024, AstraZeneca and MSD announced positive results for Lynparza® in the treatment of breast cancer, demonstrating a reduced risk of death by 28%.

However, the SMC did not recommend reimbursement of Eisai and Biogen’s Leqembi® (lecanemab) for treating early-stage Alzheimer’s disease in adults who carry one or no copies of a gene called ApoE4.  The committee cited uncertainties surrounding the drug’s clinical benefits and concerns about its cost-effectiveness, but has invited a resubmission addressing those uncertainties.

The rejection follows a similar decision by the UK’s NICE in August 2024, which found that the benefits of lecanemab were too small to warrant making the drug available on the NHS.  On 28 January 2025, the European Commission asked the Committee for Medicinal Products for Human Use (CHMP) to re-consider the positive opinion granted to Leqembi® in November 2024 for early Alzheimer’s disease following safety information that has since become available.

On 28 January 2025, the European Commission asked the Committee for Medicinal Products for Human Use (CHMP) to re-consider the positive opinion granted to Eisai/Biogen’s Leqembi® (lexanemab) in November 2024 for early Alzheimer’s disease following safety information that has since become available.  The CHMP is expected to provide its response after its plenary meeting in February 2025.  According to Biogen, “the safety profile of Leqembi® reported in clinical practice in the United States, Japan and other countries after launch is consistent with that in the approved labels, and no new safety signals are identified”. 

In other news for the product, on 26 and 27 January 2025, Eisai and Biogen announced that the US FDA has approved Leqembi® for once every four weeks intravenous (IV) maintenance dosing, indicated for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease.  Patients may transition to four-weekly dosing after 18 months of a fortnightly initiation phase.

Earlier this month, Eisai and Biogen also announced that the US FDA accepted Eisai’s BLA for Leqembi® subcutaneous autoinjector for weekly maintenance dosing for the same indications.

Leqembi® is approved for MCI and Early Alzheimer’s disease in the UK, US, Japan, China, South Korea, Mexico, Hong Kong and Israel, and the UAE.  According to Eisai, applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, Saudi Arabia and Switzerland.  In October 2024, Australia’s Therapeutic Goods Administration (TGA) rejected Leqembi® due to safety and efficacy concerns.

On 26 and 27 January 2025, Eisai and Biogen announced that the US FDA has approved Leqembi® (lecanemab-irmb) IV maintenance dosing for the treatment of Alzheimer’s disease in patients with mild cognitive impairment (MCI) or mild dementia stage of disease.  The sBLA for monthly Leqembi® IV maintenance dosing had been accepted by the FDA in June 2024.

This news comes two weeks after the US FDA accepted Eisai/Biogen’s Biologics Licence Application for Leqembi® subcutaneous autoinjector for weekly maintenance dosing for the same indication.

Leqembi® is approved for MCI and Early Alzheimer’s disease in the UK, US, Japan, China, South Korea, Mexico, Hong Kong and Israel, and the UAE.  In November 2024, the product received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.  Earlier announcements made by Eisai note that applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, Saudi Arabia and Switzerland.  In October 2024, Australia’s Therapeutic Goods Administration (TGA) declined to approve Leqembi® due to safety and efficacy concerns.

On 13-14 January 2025, Eisai and Biogen announced that the US FDA has accepted Eisai’s Biologics Licence Application (BLA) for Leqembi® (lecanemab-irmb) subcutaneous autoinjector for weekly maintenance dosing for the treatment of Alzheimer’s disease in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease.

This acceptance follows the completion of Eisai’s fast-tracked BLA in October 2024.  Leqembi® is approved for MCI and Early Alzheimer’s disease in the UK, US, Japan, China, South Korea, Mexico, Hong Kong and Israel, and the UAE.  In November 2024, the product received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

Earlier announcements made by Eisai note that applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, Saudi Arabia and Switzerland.  In October 2024, Australia’s Therapeutic Goods Administration (TGA) rejected Leqembi® following safety and efficacy concerns.  The US FDA accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly Leqembi® IV maintenance dosing in June 2024.

On 5 December 2024, Eisai announced that it has received approval for Leqembi® (lecanemab) for use in the treatment of Early Alzheimer’s Disease from Mexico’s Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico.

This news follows approval of Leqembi^® in the UK for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease in August 2024.  Leqembi® is approved for MCI and Early Alzheimer’s disease in the  UK,  US,  Japan,  China,  South Korea,  Hong Kong and Israel, and the UAE.  Earlier announcements made by Eisai note that applications are under review in the EU, Brazil, Canada, India, Russia, Taiwan, Singapore, Saudi Arabia and Switzerland.  In October 2024, Australia’s Therapeutic Goods Administration (TGA) rejected Leqembi® following safety and efficacy concerns.

On 28 November 2024, each of Eisai and Biogen announced the launch of Leqembi® (lecanemab) in Korea for the treatment of adult patients with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD dementia (early AD).  The product was approved by Korea’s Ministry of Food and Drug Safety (MFDS) in May 2024. 

Earlier this month, Eisai announced that it had received a positive opinion from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval of Leqembi®.  

Leqembi® is approved for MCI and Early Alzheimer’s disease in the  UK,  US,  Japan,  China,  South Korea,  Hong Kong and Israel, and  the UAE.  Earlier announcements made by Eisai note that applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland.  In October 2024, Australia’s TGA rejected Leqembi® following safety and efficacy concerns.