RegulatoryCompany release

Vera Therapeutics books $10.3m Trutakna sales and files for full FDA approval in IgAN

🇺🇸 Vera Therapeutics, Inc. (VERA) · Thu 05 Nov 2026

The company reported first sales of its IgA nephropathy therapy after July's accelerated approval and has asked the FDA to convert it to full approval, with an EMA filing planned for early 2027.

Vera Therapeutics reported third-quarter 2026 results on 5 November, disclosing net sales of $10.3 million for Trutakna (atacicept-vymj). The product is the company's first on the market, and the figure covers the period after its US launch.

The US Food and Drug Administration granted Trutakna accelerated approval on 7 July 2026 to reduce proteinuria in adults with primary IgA nephropathy (IgAN).

On 3 November Vera submitted a supplemental biologics licence application (sBLA) seeking full approval. The filing rests on two-year data from the ORIGIN 3 study. The company expects an FDA decision in mid-2027.

Vera also said it intends to submit a marketing authorisation application to the European Medicines Agency in the first quarter of 2027.

For context, accelerated approval in the US allows a medicine to reach patients on the basis of a surrogate endpoint, such as reduced proteinuria, with continued approval typically dependent on confirmatory evidence of clinical benefit.

What it means for your team

  • Regulatory teams should note the mid-2027 FDA decision target for conversion from accelerated to full approval, and the planned EMA submission in Q1 2027.
  • Market-access teams in Europe should prepare for a potential new IgAN option, though no EU timeline beyond the planned filing has been given.
  • Pharmacovigilance teams should expect post-marketing safety data collection to build as US use grows following the July launch.

Company's press release (SEC filing): Vera Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Vera Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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