FDA: Reata kidney drugs cannot effectively slow disease progression
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FDA(13:0): Reata kidney drugs cannot effectively slow disease progression
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FDA(13:0): Reata kidney drugs cannot effectively slow disease progression.
A few days ago, the FDA expert advisory panel voted 13 votes against and 0 votes in favor, unanimously that Reata Pharmaceuticals’ chronic kidney disease (CKD) drugs are ineffective.
The committee stated that based on the data submitted by Reata, the committee believes that bardoxolone does not effectively slow down the progression of chronic kidney disease in patients with Alport syndrome and failed to prove that the clinical benefits of the drug outweigh its risks.
Because the US FDA held a meeting of the Cardiovascular and Renal Drug Advisory Committee, the company’s stock was suspended from trading on Wednesday.
The biotech company’s stock price reached $78.83 per share last week and closed at $54.42 per share on Tuesday.
After the expert committee voted, the US FDA will decide the final fate of the drug on February 25, 2022, and the expert committee’s opinions will be of great reference to this decision.
The review team of the FDA regulatory agency wrote in the briefing that the data of the trial results did not show that the drug was slowing down the loss of renal function or reducing the risk of accumulated renal failure, and the company did not submit animal models from Alport syndrome or other sufficient And the data from well-controlled AS or CKD clinical trials, the submitted data cannot prove whether the therapy can inhibit the loss of renal function.
The therapy is an under-research, once-a-day, oral Nrf2 activator. Bardoxolone can selectively bind to Keap1. Keap1 protein can control the activity of Nrf2 in response to cellular stress.
By combining with Keap1, bardoxolone can stabilize Nrf2 and increase its activity.
Unlike other PAH therapies, bardoxolone directly improves the mitochondrial function and energy production of skeletal muscle cells, and does not affect systemic hemodynamics.
In the United States, bardoxolone has been granted Orphan Drug Designation (ODD) for the treatment of Alport syndrome and autosomal dominant polycystic kidney disease (ADPKD), and in the European Union, bardoxolone has also been awarded the ODD for the treatment of Alport syndrome.
If the bardoxolone therapy is finally approved, the Reata drug will also become the first drug approved for the treatment of Alport syndrome.
The US FDA stated that this rare genetic disease can lead to gradual loss of kidney function and kidney failure, as well as deafness and potential vision loss.
Although bardoxolone achieved its primary and key secondary goals in a phase 3 trial called CARDINAL, experts from the US FDA review team questioned whether the drug actually slowed the progression of the disease.
CARDINAL Phase 3 clinical trial is a double-blind, placebo-controlled, randomized trial. The results of the trial showed that compared with the placebo group, the renal function of patients in the bardoxolone treatment group was measured by eGFR in the 100th week and the 104th week.
Significant improvement has taken place in school. In this study, bardoxolone was well tolerated and its safety profile was similar to that observed in previous trials.
The reported adverse events (AE) were mostly mild to moderate.
Compared with placebo-treated patients, the most common adverse events in bardoxolone-treated patients were muscle cramps and elevated transaminases.
In 2019, AbbVie ended its 9-year partnership with the biotech company on the drug. Reata paid $300 million to AbbVie to regain the rights to bardoxolone.
The CEO of the biotechnology company claimed that AbbVie had not actively participated in the cooperation in recent years. The Plano, Texas-based biotechnology company first submitted documents for approval to the U.S. FDA in February this year.
Before submitting the document, Reata met with the US FDA in January and September 2020 to obtain possible accelerated approval.
However, based on an interim analysis of the Phase 3 trial, US regulators did not agree with Reata’s proposed approach, and the company eventually abandoned the regulatory path for accelerated approval.
According to a forecast report released by Evaluate Pharma, a medical market research agency, early sales of bardoxolone after its successful launch are expected to be very small, but it will quickly reach a US$1 billion blockbuster market position in 2024, with sales expected to be US$1.12 billion by 2026.
It will further accelerate to 2.5 billion U.S. dollars this year.
Reference：
FDA advisers unanimously agree Reata’s kidney drug is not effective at slowing disease progression
FDA(13:0): Reata kidney drugs cannot effectively slow disease progression
(source:internet, reference only)
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