Biogen and Eisai, two pharmaceutical firms, said on Tuesday that a medicine that they are developing for Alzheimer’s disease has reduced the pace of cognitive deterioration in a massive clinical study that was in the late stages.
The positive findings increase the likelihood that the medicine will be granted approval and provide a fresh source of optimism for a group of Alzheimer’s drugs that have repeatedly been unsuccessful or have yielded mixed outcomes.
The encouraging statistics give Biogen a second shot after the company’s marketing of another Alzheimer’s medicine, which was called Aduhelm, was a complete and utter failure. This prescription was given regulatory clearance the year before last despite their being no evidence that it may delay cognitive decline. However, Medicare only covered a very little portion of the cost of this medication, and it has been a commercial flop.
The effectiveness of the new treatment, lecanemab, seems to have increased. In the research study, which involved over 1,800 people with moderate cognitive impairment or mild Alzheimer’s disease, the businesses reported that cognitive deterioration was decreased by 27 percent in the group of volunteers who got lecanemab in comparison to the group who received a placebo.
The clinical trial of lecanemab, which is given as an intravenous infusion, was the largest one that had been conducted to date to investigate whether or not removing plaques from the brain that had been formed by the accumulation of a protein called amyloid could slow the progression of Alzheimer’s disease. A comparable functionality is intended to be provided by Aduhelm.
Some individuals on lecanemab had brain edoema or bleeding, similar to prior anti-amyloid treatments; however, the incidence of these adverse effects was lower than with Aduhelm and other experimental therapies.
Eisai had previously submitted an application for an expedited approval, which is the kind of permission that was granted to Aduhelm. The procedure gives the Food and Drug Administration permission to approve drugs even if they have inconclusive evidence that they are beneficial to patients, but they do affect the biological pathway that is associated with a disease in a way that is thought to have a good chance of being beneficial to patients.
The firm said on Tuesday night that it will first proceed with the expedited approval process, with a decision from the FDA scheduled to be made by the beginning of January, and then utilise the more recent data to pursue full clearance of its product.
Some experts claimed the drug’s capacity to decrease cognitive deterioration — by 0.45 on an 18-point scale — was small at best and may not be a difference that patients in the moderate early stages of the illness would notice.
Before the release of Aduhelm, the market for Alzheimer’s medications had not witnessed the introduction of a new therapy in over two decades; other businesses are now working on therapies that have the potential to disrupt this market. It is anticipated that Roche will announce the results of two trials concerning a medication known as gantenerumab before the year comes to a close. Early in the new year, the F.D.A. is anticipated to make a decision regarding whether or not to grant accelerated approval to a drug developed by Eli Lilly called donanemab for the treatment of Alzheimer’s disease. The findings of a more extensive study of the drug are scheduled to be released in the middle of the following year.
According to Mr. Skorney, the findings of the research conducted on lecanemab “established a high standard” that he believes would be difficult to surpass for future medications, even if they prove to be effective.
