FDA Clears Replimune Melanoma Drug; CMS Delays AbbVie Talks
Get the Health newsletter
Daily health & science — research, biotech, public health, the studies worth knowing. Free.
- FDA granted accelerated approval to Replimune's advanced melanoma treatment, to be marketed as Tudriqev, following a supportive vote from agency advisers the previous week.
- FDA staff had flagged concerns about the design and conduct of the key trial, but advisers found a sufficient efficacy signal given patients' urgent need for new treatments.
- A little-noticed Medicare policy shift caused a seven-year delay in selecting a costly AbbVie medicine for federal price negotiations, likely hurting taxpayers according to a consumer advocacy group analysis.
- CMS modified its drug-selection criteria as it prepared a new round of talks under the Inflation Reduction Act — a change that benefited AbbVie and could help other drugmakers.
- Replimune's approval ends a tumultuous saga for the biotech, which had struggled for months to win FDA backing for the controversial treatment.
Why it matters: Replimune's win shows the FDA is willing to override staff trial-design objections when advisory votes and patient urgency align, while CMS's quiet criteria revision stretches out the Inflation Reduction Act's negotiation timeline, postponing any taxpayer savings on AbbVie's costly medicine.
Ask SkimNews
