Ardelyx hopes to provide patients with chronic kidney disease with a new and more convenient option to solve their complications. The U.S. Food and Drug Administration restricted these plans on Thursday, Refuse The biotech company’s drugs and asked the company to conduct another clinical trial to prove the effectiveness of the therapy.
The company stated that the agency’s letter expressed its willingness to meet with the company to discuss options for seeking regulatory approval for the drug Tenapanor. Ardelyx divides its operations into Fremont, California and Waltham, Massachusetts, and the company said it plans to request a meeting with the FDA as soon as possible.
People with chronic kidney disease may accumulate phosphate levels in the blood. The main treatment option is phosphate binders, which are drugs that bind to phosphate and prevent it from being absorbed by the body. However, the phosphorus binder must be taken with multiple tablets per meal. Tenapanor is a single pill that is taken twice a day. In addition to convenience, it is also hoped that Ardelyx drugs can provide better efficacy.
Ardelyx drugs are not phosphate binders. This small molecule is designed to act locally in the intestine to block a protein called sodium-hydrogen exchange3. According to the company, doing so will tighten the connections of intestinal epithelial cells, thereby reducing the absorption of phosphate. Ardelyx tested three drugs Phase 3 study More than 1,000 patients were enrolled. Two of the studies tested the drugs individually, and one evaluated the combination of pills and phosphate binders.
The complete response letter is not a public document. According to Ardelyx’s account of the communication, the FDA agrees that the data provides “a large amount of evidence that Tenapanor can effectively reduce serum phosphorus” [chronic kidney disease] Dialysis patients. “But the company said that the agency described the extent of the therapeutic effect as “small and unclear in clinical significance.” In order to show clinically relevant effects, the FDA stated that the company must conduct another study. Ardelyx said that the FDA did not mention in the letter. To any safety or manufacturing issues.
Ardelyx President and CEO Mike Raab said in a prepared statement: “We disagree with the FDA’s subjective evaluation of the clinical relevance of Tenapanor treatment in our study. These evaluations meet all clinical endpoints agreed by the FDA. “In our opinion, in all of our clinical studies, the serum phosphorus reduction data generated by tenapanor is meaningful and clinically meaningful. We will work with the agency to solve the problems raised and find a quick one if possible. The way forward.”
Signs that new drug applications may be in trouble appeared in the spring. In April, the FDA required Ardelyx More analysis Clinical data to better understand how the drug compares to approved therapies. The information requested was a major revision of the application, which resulted in an extension of the target decision date by three months.Last week, Ardelyx disclosed that the regulator sent Another letter It stated that its review of the application “confirmed that labeling and post-marketing requirements/commitments cannot be discussed at this time.” Ardelyx stated that its request to meet with regulators was rejected.
Tenapanor is the most advanced drug candidate for Ardelyx, a biotechnology company that develops drugs for the treatment of kidney and heart and kidney diseases. At the end of the second quarter of this year, Ardelyx reported a cash position of $171.8 million.
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