An individual skateboards previous Biogen Inc. headquarters in Cambridge, Massachusetts, on Monday, June 7, 2021.
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Biogen isn’t frightened about competing with Eli Lilly as they each try and carry an Alzheimer’s drug to the market, Biogen’s CEO mentioned Tuesday.
“I believe it is going to be good if there are different gamers in the market, however I do not suppose we’re too concerned about competing with donanemab,” Christopher Viehbacher, the chief govt, mentioned throughout the firm’s first quarter earnings name, referring to one among Eli Lilly’s potential Alzheimer’s remedies.
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Clinical trial information on each Eli Lilly’s donanemab and leqembi, a extremely anticipated drug from Biogen and Japanese drugmaker Eisai, point out they scale back a protein known as amyloid. The protein builds up on the mind in Alzheimer’s sufferers and disrupts cell operate.
Researchers argue that the accumulation of amyloid plaque is a vital first step towards the cognitive decline noticed in Alzheimer’s illness. More optimistic information on donanemab “additional reinforces” that argument, in line with Viehbacher.
But he mentioned Eli Lilly’s resolution to cease dosing the drug after it clears a certain quantity of amyloid plaque in a affected person is probably not the finest method to treating the illness.
“Most neurologists I talked to do not imagine that matches anymore with the approach we’re pondering about the remedy of Alzheimer’s,” Viehbacher mentioned.
Eli Lilly did not instantly reply to a request for remark.
Patients in a phase two trial on donanemab stopped dosing as early as six months resulting from clearing amyloid plaque in their brains. Fewer than 100 sufferers acquired 12 months of the drug.
The Food and Drug Administration declined to grant accelerated approval for donanemab in half resulting from the lack of information on long run use of the drug.
Read extra: FDA grants accelerated approval for Biogen ALS drug that treats rare form of disease
Viehbacher famous that amyloid plaque will accumulate in the mind once more even after an Alzheimer’s drug manages to clear it. He mentioned that can seemingly require Eli Lilly and Biogen to roll out upkeep doses that can maintain plaque ranges low.
Biogen and Eisai expect the Food and Drug Administration to grant full approval of leqembi by the summer time. The firms are already getting ready to use for approval of upkeep doses by the first quarter of 2024, Biogen mentioned in its first quarter earnings report.
Eli Lilly has not introduced related upkeep dosing plans for donanemab. The firm plans to unveil information from a part three trial on donanemab throughout the second quarter this yr.
The two drugmakers are racing to carry a brand new Alzheimer’s remedy to the market after each of their earlier medication flopped.
Biogen is banking on the success of its drug leqembi after the disastrous approval and rollout of its outdated Alzheimer’s drug aduhelm final yr.
The firm mentioned it booked an $18 million loss from Alzheimer’s illness remedies throughout the first quarter.
Eli Lilly is growing donanemab and one other drug, remternetug, after the firm’s older remedy, solanezumab, didn’t gradual the development of Alzheimer’s in scientific trials.
An estimated 6.7 million Americans age 65 and older live with Alzheimer’s, in line with the Alzheimer’s Association. By 2050, that group is projected to rise to nearly 13 million.
One in three seniors die with Alzheimer’s or one other type of dementia, which kills extra individuals than breast most cancers and prostate most cancers mixed, the affiliation mentioned.
