FDA Approves Vera's $425K Trutakna for Kidney Disease
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- Vera Therapeutics received FDA approval for Trutakna, a drug for IgA nephropathy — a condition where immune antibodies accumulate in the kidneys — and will charge $425,000 annually before customary insurance discounts and rebates.
- Trutakna enters a crowded field: the source notes it is one of several drugs now entering or nearing the market for IgA nephropathy.
- U.K. officials are nearing a drug-pricing deal with AstraZeneca and Daiichi Sankyo to provide access to Enhertu, an antibody-drug conjugate shown to extend survival for certain breast cancer patients by roughly six months.
- Enhertu had previously been deemed not cost-effective by the U.K. drug-pricing regulator, but the U.K. later changed its drug-pricing metrics as part of a trade deal with the Trump administration.
- Under the proposed deal, certain women in England and Wales would receive Enhertu, a drug already widely available in other countries.
Why it matters: The $425,000 list price for Trutakna lands in a market where multiple IgA nephropathy drugs are entering or nearing launch, so real-world access will hinge on payer negotiations rather than FDA clearance. The U.K.'s reversal on Enhertu shows how its post-trade-deal pricing framework is now unlocking drugs previously blocked on cost-effectiveness grounds — a quiet but concrete pharma-policy payoff from the U.S. trade deal.
