Given the demand for a potential disease-modifying therapy for the disease, early demand for Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) is considerable from patients. Many neurologists, however, continue to view the drug with skepticism.
Fewer than half of neurologists expect they will prescribe the drug in the first six months of availability, according to research from Spherix Global Insights.
Still, many neurologists are receiving a flood of queries about Aduhelm. “We’ve received a lot of inquiries from patients themselves, a lot more referrals from primary care doctors, geriatrics doctors, internal medicine doctors who actually have no idea what aducanumab is, and they just are referring a bunch of patients themselves,” said private-practice neurologist Dr. Roni Sharon in a briefing note with UBS analysts.
Demand for an effective Alzheimer’s treatment is considerable. “Family members have been coming in inquiring about the medicine,” Sharon told UBS analysts. “They just hear that there’s an amazing breakthrough therapy that’s come out for Alzheimer’s.”
Doctors could have less of an opportunity than usual to review the drug. While pharma companies generally publish clinical trial results before receiving regulatory approval, such has not been the case for Aduhelm. According to media reports, Biogen had submitted an article to JAMA, but the journal requested edits to it, prompting Biogen to withdraw the paper.
A Biogen spokesperson noted that JAMA did not reject the article but that the company withdrew it to “pursue other publication opportunities.”
Critics, including members of an FDA advisory committee, have concluded that there is insufficient evidence to warrant approval of the drug.
The adverse events linked to the drug are also not insignificant. According to the FDA, common adverse events include amyloid-related imaging abnormalities (ARIA) and related symptoms. The FDA label for the drug lists “ARIA-Edema, headache, ARIA-H microhemorrhage, ARIA-H superficial siderosis, and fall” as potential side effects.
In clinical trials, ARIA occurred in 41% of patients receiving high doses of aducanumab, which is what is now FDA-approved.
The “side effect profile is huge,” Sharon said. “I have to be honest with you. I’ve never given a medication to such healthy people with such a significant side effect profile.”
Sharon said he is reserving the use of the drug to patients with mild cognitive impairment and early mild Alzheimer’s.
Biogen and its partner Eisai have announced that they are sharing data related to the drug at the Alzheimer’s Association International Conference, held from July 26–30.
In particular, the companies will share data from the Phase 3 EMERGE trial, which they state “shows consistency in slowing decline across cognitive, functional and behavioral measures in early Alzheimer’s disease.”
Filed Under: clinical trials, Drug Discovery, Neurological Disease