Eli Lilly’s Alzheimer’s drug receives approval from US FDA
After facing several hurdles on its path to approval last year, Eli Lilly’s donanemab treatment for early Alzheimer’s, brand name Kisunla, received US FDA approval this past week. It is the second therapy for slowing the progression of Alzheimer’s now available to US patients.
Earlier this year, the treatment received a recommendation from an independent advisory board despite concerns over certain adverse effects. The board was unanimously in favour of the treatment. This latest milestone for the drug product is a huge achievement for all stakeholders. “This is real progress,” commented Joanne Pike from the Alzheimer’s Assocation. “Having multiple treatment options is the kind of advancement we’ve all been waiting for – all of us who have been touched, even blindsided, by this difficult and devastating disease.”
Donanemab works by clearing a protein called beta-amyloid from the brain, which has been shown to influence the progression of Alzheimer’s. Eli Lilly’s Kisunla differs from the already approved Leqembi from Eisai and Biogen is its finite dosing – patients do not need to continue taking the drug once brain scans are clear of amyloid plaques. However, Eli Lilly’s Kisunla is priced at US$32,000 for a 12-month course while Eisai’s is priced at US$26,500. Analysts attribute this to the non-chronic nature of the treatment compared with Leqembi. “The details of how it will play out in clinical practice are still unclear but I think it will save a lot of money and patient will like it a lot better,” stated Erik Musiek, neurologist at Barnes-Jewish Hospital. “I think that, coupled with monthly dosing, [this] will make this an attractive option.”
A late-stage trial of donanemab demonstrated slowed progression of memory and thinking problems by 29% compared with a placebo. However, like Eisai’s Leqembi, mild brain swelling and brain bleeding were observed in a few patients. The US FDA will be placing boxed safety warnings for potential brain swelling and bleeding on Kisunla, as it has for Leqembi. While Eisai’s product only requires four MRI scans to check for side effects, Kisunla will require five. This may provide some advantage for regions where access to scans is more difficult. Kisunla is expected to be available mostly for patients enrolled in Medicare age 65 and over.
Source:
Eli Lilly Alzheimer’s drug approved by US FDA [Accessed July 4, 2024] https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-lillys-alzheimers-drug-2024-07-02/
Related News
-
News This week in GLP-1 drug headlines: Manufacturing investment and new market launches
As drugmakers race to put their own GLP-1 drug products forward as the next biggest thing in weight-loss, current products are making numerous headlines this week with a number of new developments in their commercialisation and approval. Discover the l... -
News Women in Pharma: Regulating equity across regional borders
In our monthly series focusing on women in the pharmaceutical industry, we interview leading experts in the pharmaceutical supply and value chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News Viral marketing for B2B pharma businesses: a CPHI Online case study
Discover how a Chinese chemical manufacturing company went viral on TikTok, and what their viral success means for the future of B2B digital marketing for the wider pharmaceutical industry and supply chain. -
News New Aurigene biologics facility opens in Hyderabad, India
Aurigene Pharmaceutical Services Ltd. have opened a biologics facility in Hyderabad, India in a biocluster known as Genome Valley. -
News Novo Nordisk launches 'Power of Wegovy' national campaign
Danish drugmaker Novo Nordisk have launched a new national campaign – The Power of Wegovy – that aims to educate those living with obesity on their blockbuster drug Wegovy throughout the United States. -
News Women in Pharma Anniversary: Celebrating Our Heroines of Pharma
Our Women in Pharma interview series is approaching its 1-year anniversary this month, and to celebrate, we are highlighting the Heroines of Pharma that our very own Women in Pharma admire. -
News Sanofi gains rare disease therapy in acquisition of Inhibrx for US$1.7 billion
Sanofi completed the acquisition of the clinical-stage biotech company Inhibrx in late May 2024 after settling on a US$1.7 billion buyout. The acquisition brings with it a rare disease therapy to bollster Sanofi's pipeline. -
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance