Otsuka's Voyxact faces rival as FDA okays Vera IgAN drug

Vera Therapeutics has won FDA approval for Trutakna, a BAFF/APRIL inhibitor for IgA nephropathy (IgAN) that will compete with Otsuka's recently approved anti-APRIL drug Voyxact.

Trutakna (atacicept) has been granted an accelerated approval to reduce proteinuria in adults with primary IgAN who are at risk of disease progression – the same indication as Voyxact (sibeprenlimab), which became the first anti-APRIL drug to reach the US market last year.

Trutakna is the first dual BAFF/APRIL drug to be cleared by the FDA, targeting two proteins involved in survival and maturation of certain immune cells in IgAN, a rare autoimmune kidney disorder and a leading cause of kidney failure. It causes antibodies to accumulate in the kidneys, causing inflammation and scarring, and affects around 160,000 people in the US.

The green light for Vera's drug comes on the back of interim data from the ongoing ORIGIN 3 trial, in which a once-weekly, subcutaneous injection of Trutakna achieved a 46% reduction from baseline in proteinuria, with a statistically significant and clinically meaningful 42% reduction compared to placebo at 36 weeks.

Upgrading to full approval will depend on Trutakna showing that it can delay kidney function decline over the long-term in patients with IgAN, an endpoint which is also being tracked in ORIGIN 3.

Otsuka is facing a similar situation with Voyxact, and already has data in hand on kidney function over two years from the VISIONARY study and is preparing to file a rolling application for full approval later this year.

Vera said it was launching its first commercial drug straight away with a list price of $425,000 per year, which comes in higher than the estimated $390,000 annualised cost of Voyxact, which is administered as a subcutaneous injection once a month.

The company's chief executive, Marshall Fordyce, said that Trutakna represents "an important milestone" for IgAN patients and "has the potential to meaningfully transform the treatment landscape."

Crowded market

Both Trutakna and Voyxact have entered an increasingly crowded IgAN market in the US, where there were no approved therapies until 2021, when Calliditas Therapeutics launched steroid-based Tarpeyo (budesonide). Now there are six, with more likely on the way.

While Trutakna is competing directly with Voyxact, it will also contend indirectly with Tarpeyo and other drugs with different mechanisms of action, namely Travere Therapeutics' endothelin-1/angiotensin-2 inhibitor Filspari (sparsentan), and Novartis' Factor B inhibitor Fabhalta (iptacopan) and endothelin A receptor antagonist entrant Vanrafia (atrasentan).

Novartis also has an anti-APRIL antibody called zigakibart in phase 3 testing, while other candidates in late-stage development include AstraZeneca's complement C5 inhibitor Ultomiris (ravulizumab), Vertex's recently filed BAFF/APIL antagonist povetacicept, Ionis/Roche's antisense-based Factor B inhibitor IONIS-FB-LRx/RG6299, and Biogen's anti-CD38 antibody felzartamab.