Concerns about the potential safety of AAV-based gene therapies have not stopped AbbVie from in-licensing development rights for Regenxbio's wet age-related macular degeneration (AMD) treatment RGX-314.
A new academic study highlights what may be an underestimated potential for risks associated with Biogen and Eisai's controversial Alzheimer's disease drug Aduhelm and one of its authors told FirstWord this week he is hopeful it will provide useful context for how the product will be covered under Medicare.
Researchers from Harvard Medical School and the University of Michigan have published a letter in the Journal of the American Medical Association that examined Medicare claims and found that 85% of patients with mild cognitive impairment (MCI) and 91% of those with early AD would be ineligible for participation in the pivotal trials of Aduhelm. More here.
It comes just days after Biogen's acknowledgment that initial sales of Aduhelm have been more sluggish than expected, with one of the key impediments being the wait for CMS to issue a national coverage determination on how and when the drug will be covered under Medicare.
FirstWord's Physician Intelligence has consistently shown that US neurologists are sceptical about the clinical benefits of Aduhelm, with a recent poll suggesting that the FDA made a major misstep in approving the drug.
The 2021 ESMO congress takes place this weekend (16-21 September).
Highlights are likely to include new KRAS inhibitor data in colorectal cancer, detailed results for AstraZeneca and Daiichi Sankyo's Enhertu in second-line HER2-positive breast cancer and updated readouts for a raft of cancer immunotherapies.
Whether US ophthalmologists think new data for Apellis Pharmaceuticals' geographic atrophy treatment is compelling enough to secure approval (and if so, what level of adoption) - results from this poll are coming soon!