Friday Five – The Pharma Week in Review (17 September 2021)

AbbVie targets eye disease for gene therapy move

  • 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.
  • AbbVie will pay $370 million upfront as part of deal potentially worth $1.7 billion.
  • Unlocking the commercial potential of RGX-314, touted as a possible 'one time' treatment for AMD could depend largely on whether less invasive suprachoroidal dosing is effective. Interim Phase II data are expected later this month; the timing of AbbVie's deal suggests these results are encouraging.

mRNA momentum in China

Another challenge for Aduhelm

  • 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.

ESMO preview

  • 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.
  • Read our preview here.

What we asked physicians this week…

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