Pharmaceutical Executive Daily: FDA Grants Traditional Approval to Novartis's Fabhalta

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today's Pharmaceutical Executive Daily, FDA converts Fabhalta's accelerated approval to full approval for IgA nephropathy, a Pharmaceutical Executive commentary argues AI-driven patient support still can't replace human connection, and Jasper Therapeutics closes its acquisition of Kira Pharmaceuticals in a deal combining a three-asset immunology pipeline.

FDA has granted traditional approval to Novartis's Fabhalta to slow kidney function decline in adults with primary IgA nephropathy, converting the drug's 2024 accelerated approval, which was based on reducing proteinuria, into a full approval. The decision rests on confirmatory Phase III data from the Applause-IgAN trial, which showed the oral complement inhibitor slowed the annual decline in kidney filtration rate by 2.7 milliliters per minute per 1.73 square meters compared with placebo over two years. Fabhalta works by inhibiting Factor B in the alternative complement pathway, a key driver of kidney inflammation in the disease. The drug carries an increased infection risk and remains available only through a restricted safety program requiring vaccination beforehand.

A new commentary in Pharmaceutical Executive argues that as patients increasingly turn to AI for health information, replacing what used to be called Dr. Google, pharma's patient support programs risk over-relying on chatbots at the expense of human contact. The piece cites survey data showing many patients with chronic conditions report medication adherence problems tied to loneliness, and points to a 2026 study finding a majority of organizations have had to roll back live AI customer service agents. The author advocates a hybrid model, using AI to flag at-risk patients while keeping trained peer supporters responsible for the actual outreach and follow-up calls.

Finally, Jasper Therapeutics has completed its all-stock acquisition of Kira Pharmaceuticals, combining the two companies into a three-asset immunology pipeline spanning complement inhibition, transplant and mast cell indications, and autoantibody-driven disorders. The deal closed alongside a $132 million private placement that Jasper says extends its cash runway through the second half of 2028. The lead combined asset, Kp-104, is a Phase II/III-ready complement biologic with interim data expected later this year and in 2027. Kira is separately out-licensing two additional complement assets to Mirador Therapeutics as part of the transaction.

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