Calliditas’ kidney disease drug granted priority review by FDA
pharmafile | April 28, 2021 | News story | Research and Development | Calliditas, FDA, nephropathy, pharma, pharma news
The FDA has granted priority review for the New Drug Applicaton (NDA) for Calliditas Therapeutics’ Nefecon, for the treatment of IgA nephropathy (IgAN) – a disease that causes damage to kidney tissues.
The NDA submission was based on positive data from a randomised, placebo-controlled Phase III study. The trial, which featured 200 patients with IgAN, achieved its primary endpoint of proteinuria reduction (a reduction of protein in the urine), in those taking the treatment, compared to those on placebo.
The study also showed a stabilisation of eGFR number – a test to measure level of kidney function – after nine months.
Nefecon is an oral formulation of budesonide – a medicine commonly used for asthma, among other treatments. The Nefecon formulation is designed to deliver the drug to the Peyer’s patch region of the lower small intestine, where IgAN originates. The drug can then be released in pulses once it reaches its target in the lower small intestine.
Calliditas has applied for accelerated approval for its treatment, which allows drugs targeting serious conditions that fill an unmet medical need to be approved based on a surrogate endpoint.
Renée Aguiar-Lucander, Calliditas CEO, said: ”We are very excited about being granted priority review, which reflects the unmet medical need of IgAN. We look forward to engaging with the agency and work towards an accelerated approval later this year so that we will be in a position to provide the first approved medication for IgAN patients.”
Andrew Udell, Head of North America Commercial at Calliditas, added: ”Having a target action date provides us with a clear timeline as we continue to expand our US organisation and prepare for commercialisation in the fourth quarter of this year, subject to approval.”
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of September 15. A PDUFA date is a time by which the FDA collects fees from drug manufacturers to fund the new drug approval process.
Jack Goddard
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