Latest news with #Biogen
Boston Globe
2 days ago
- Health
- Boston Globe
Biogen sees potential in combining Alzheimer's and obesity drugs
Advertisement Biogen's looking to the growth of its Alzheimer's drug Leqembi to offset the decline of its multiple sclerosis franchise, which is facing competition from cheaper generic drugs. Biogen's new Alzheimer's drug is already facing competition from Eli Lilly & Co.'s Alzheimer's drug, which was approved in the US last year and has since captured around 30 percent of the market, according to analysts. Other companies are also circling. Novo is carrying out clinical trials to assess whether the main ingredient in diabetes drug Ozempic and weight-loss shot Wegovy might help people with early Alzheimer's disease. Research suggests that the weight-loss drug could slow Alzheimer's progression by impacting inflammation and vascular health. Results of Novo's late-stage trial are expected later this year. Advertisement Viehbacher noted that being overweight is a risk factor for Alzheimer's. He cautioned the Novo study 'is a fairly risky proposition,' adding that 'most of the experts we're talking to are not convinced that it will work.' 'It's logical if you have a weight-loss drug that you can see some benefit, but it's actually pretty hard to move the needle on the cognitive side,' Viehbacher added. Alzheimer's drug development has been riddled with failures, even when drugs looked promising in early studies. Leqembi is a partnership between Cambridge, Massachusetts-based Biogen and Japanese drugmaker Eisai Co. Biogen makes the active ingredient for Leqembi in Switzerland. The company then ships it to North Carolina, where it gets made into a product. President Donald Trump recently put a 39 percent tariff on imports from Switzerland. It's unclear whether this would impact Biogen's drug. Still, Viehbacher said the company has the ability to start producing the substance used to make Leqembi in North Carolina for the US market, while continuing to make it in Switzerland for outside the US. He said the company always intended to use its North Carolina facilities to make Leqembi and the potential move was not a direct response to Trump's tariff threats. Last month, Biogen announced it intends to invest an additional $2 billion in its existing manufacturing footprint in North Carolina's Research Triangle Park.
Mint
3 days ago
- Health
- Mint
Biogen Sees Potential in Combining Alzheimer's and Obesity Drugs
(Bloomberg) -- If Novo Nordisk A/S's wildly popular weight-loss drug succeeds in a highly anticipated trial for Alzheimer's disease, Biogen Inc.'s Chief Executive Officer Chris Viehbacher doesn't see it as a roadblock for his company's medication. Rather, he sees it as an opportunity to potentially combine drugs and create a more potent therapy. 'As we look out over the next five years, we're probably going to see a treatment much like any other complex disease,' he said in an interview with Bloomberg News, meaning there will be 'different mechanisms of action that you need.' It's not uncommon for drugmakers to study combinations of treatments when two seem to work for the same condition, in hope of boosting the benefit. Viehbacher said if Novo's study works, Biogen 'might' do trials looking at the two drugs in combination but cautioned the timeline might not make sense given Alzheimer's studies take years to complete. Biogen's looking to the growth of its Alzheimer's drug Leqembi to offset the decline of its multiple sclerosis franchise, which is facing competition from cheaper generic drugs. Biogen's new Alzheimer's drug is already facing competition from Eli Lilly & Co.'s Alzheimer's drug, which was approved in the US last year and has since captured around 30% of the market, according to analysts. Other companies are also circling. Novo is carrying out clinical trials to assess whether the main ingredient in diabetes drug Ozempic and weight-loss shot Wegovy might help people with early Alzheimer's disease. Research suggests that the weight-loss drug could slow Alzheimer's progression by impacting inflammation and vascular health. Results of Novo's late-stage trial are expected later this year. Viehbacher noted that being overweight is a risk factor for Alzheimer's. He cautioned the Novo study 'is a fairly risky proposition,' adding that 'most of the experts we're talking to are not convinced that it will work.' 'It's logical if you have a weight-loss drug that you can see some benefit, but it's actually pretty hard to move the needle on the cognitive side,' Viehbacher added. Alzheimer's drug development has been riddled with failures, even when drugs looked promising in early studies. Leqembi is a partnership between Cambridge, Massachusetts-based Biogen and Japanese drugmaker Eisai Co. Biogen makes the active ingredient for Leqembi in Switzerland. The company then ships it to North Carolina, where it gets made into a product. President Donald Trump recently put a 39% tariff on imports from Switzerland. It's unclear whether this would impact Biogen's drug. Still, Viehbacher said the company has the ability to start producing the substance used to make Leqembi in North Carolina for the US market, while continuing to make it in Switzerland for outside the US. He said the company always intended to use its North Carolina facilities to make Leqembi and the potential move was not a direct response to Trump's tariff threats. Last month, Biogen announced it intends to invest an additional $2 billion in its existing manufacturing footprint in North Carolina's Research Triangle Park. More stories like this are available on
Bloomberg
3 days ago
- Health
- Bloomberg
Biogen Sees Potential in Combining Alzheimer's and Obesity Drugs
If Novo Nordisk A/S 's wildly popular weight-loss drug succeeds in a highly anticipated trial for Alzheimer's disease, Biogen Inc.'s Chief Executive Officer Chris Viehbacher doesn't see it as a roadblock for his company's medication. Rather, he sees it as an opportunity to potentially combine drugs and create a more potent therapy. 'As we look out over the next five years, we're probably going to see a treatment much like any other complex disease,' he said in an interview with Bloomberg News, meaning there will be 'different mechanisms of action that you need.'
Japan Times
07-08-2025
- Health
- Japan Times
Japan approves price cut for Alzheimer's drug Lecanemab
A health ministry panel Wednesday approved a plan to cut the price of Lecanemab, an Alzheimer's drug codeveloped by Japanese drugmaker Eisai and U.S. industry peer Biogen, by 15% in Japan starting Nov. 1. The decision is based on an assessment by the Central Social Insurance Medical Council that cited the low cost-effectiveness of the drug used to treat dementia caused by Alzheimer's disease. The price of the drug will be lowered to ¥97,277 for a 500-milligram bottle. Dosages are based on weight. For example, a patient weighing 50 kilograms would see an annual cost reduction from about ¥2.98 million to about ¥2.53 million. Lecanemab is said to be innovative because it removes abnormal proteins that accumulate in patients' brains, and it is expected to slow the progression of the disease. The medication was subject to a system that adjusts drug prices based on cost-effectiveness for high-priced or large-market drugs. At a meeting in July, the council described Lecanemab as having low cost-effectiveness compared with existing treatments.
Medscape
06-08-2025
- Health
- Medscape
Lecanemab Preserves Memory Over 4 Years in Early AD
Continuous treatment with lecanemab (Leqembi, Eisai/Biogen) demonstrated sustained disease-modifying benefit over 4 years in patients with early-stage Alzheimer's disease (AD) enrolled in the open-label extension of the phase 3 CLARITY AD trial. Through 4 years, lecanemab 'meaningfully' delayed progression to dementia stage of disease compared to untreated observational cohorts, said study investigator Christopher van Dyck, MD, Yale University School of Medicine, New Haven, Connecticut. With 4 years of treatment, 'there is in the vicinity of a full year's time saved' in early-stage disease. In addition, more than half of patients in the low tau subgroup showed improvement in cognitive function over time, van Dyck added. The results were presented on July 30 at the Alzheimer's Association International Conference (AAIC) 2025. Widening Benefit Over Time The core CLARITY AD trial included 1795 adults with mild cognitive impairment or early AD and confirmed amyloid pathology in the brain. Treatment consisted of IV infusions of lecanemab 10 mg/kg biweekly (n = 898) or matching placebo (n = 897). After 18 months of treatment, lecanemab slowed cognitive and functional decline, as measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB), by 27% compared with placebo — an absolute difference of 0.45 points ( P = .00005). To provide context, a change from 0.5 to 1.0 on the CDR score domains of memory, community affairs, and home/hobbies reflects a shift from mild impairment to loss of independence. Of the patients who completed the core 18-month study, 95% elected to continue in the open-label extension study, with 478 patients treated for 4 years. Some of these participants transitioned to once-monthly intravenous (IV) infusions, consistent with the FDA-approved regimen, and some transitioned to subcutaneous injections, a regimen currently under review by the FDA. Over 3 years of treatment, including both the core study and the open-label extension, lecanemab demonstrated a reduction in cognitive decline of 1.01 points on the CDR-SB compared to the expected decline observed in the Alzheimer's Disease Neuroimaging Initiative (ADNI) cohort, van Dyke reported. This benefit grew more pronounced after 4 years, with a reduction of 1.75 points compared to natural history. Similarly, when benchmarked against the expected decline in the BioFINDER cohort, lecanemab showed a reduction of 1.40 points at 3 years and 2.17 points at 4 years. Through 4 years, lecanemab reduced the relative risk of progression to next disease stage by 34% compared with ADNI; 53% of lecanemab-treated patients progressed to next disease stage vs 70% of those in the ADNI cohort. Lecanemab also reduced the relative risk of progression to dementia stage by 56%; 19% of lecanemab-treated patients progressed to dementia vs 37% of ADNI patients. Earlier Treatment Better Among participants in the tau PET substudy who had low tau levels, 69% showed improvement or no decline and 56% showed improvement from baseline on the CDR-SB after 4 years of lecanemab. Similar results were seen on the AD Assessment Scale-cognitive subscale-14; 51% of patients showed improvement or no decline, and 51% showed improvement. Likewise, on the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment, 64% of patients showed improvement or no decline, and 58% showed improvement. These findings suggest that starting and maintaining treatment with lecanemab in early-stage AD may help slow clinical decline and may provide sustained benefits over the long term, van Dyck said. No new safety signals were observed in the open-label extension phase with continued lecanemab treatment over 4 years. 'Most all of the adverse events actually go down in frequency over time, and none of them go up,' he said. Rates of amyloid-related imaging abnormalities (ARIA) decreased after the initial 12 months and remained consistent throughout four years of continuous treatment. Rates of ARIA related to edema (ARIA-E) were 13% at less than 12 months and declined to 1% at 36-48 months. Rates of ARIA related to hemorrhage (ARIA-H) were 15% at less than 12 months and 9% at 36-48 months. 'Exciting' Long-Term Data Reached for comment, Rebecca M. Edelmayer, PhD, vice president of scientific engagement for the Alzheimer's Association, told Medscape Medical News it's 'exciting to see that patients continue to show less decline and potentially even improvement in their clinical scores over time' and that the safety profile is 'consistent over time without any new types of safety events.' Edelmayer also noted that the open-label extension data from CLARITY-AD are in line with other 'real-world' data presented at AAIC 2025 from clinics using lecanemab that have demonstrated 'fairly similar safety and efficacy patterns.' Also providing perspective, Howard Fillit, MD, co-founder and chief science officer of the Alzheimer's Drug Discovery Foundation, noted that the analysis didn't have a stable control group, so the comparisons lean on historical data. But the fact that some patients improved or remained stable over time with continued lecanemab dosing is a 'major advance.' 'It's actually pretty amazing because not only has this historically been thought of as a chronic, uniformly progressive and ultimately fatal disease, but we never really thought that there would be a drug, at least I didn't, that would actually improve patients on a disease-modifying basis as this drug seems to do,' Fillit, who wasn't involved in the study, told Medscape Medical News . Fillit noted that the risk-benefit profile for lecanemab in this open-label study is 'fairly favorable. The rate of serious side effects is quite low, and I think this kind of study can help allay some of those fears about side effects.' He also noted that having a subcutaneous dosing option or lecanemab (if approved) will be a 'game changer' enabling at-home dosing and reducing the burden and inconvenience of having to go to a center to get an infusion of lecanemab. The FDA is set to decide on whether or not to approve the company's biologics license application for lecanemab subcutaneous autoinjector later this month.
