By writer to www.pharmalive.com
Disappointed over the “lack of readability” within the U.S. Meals and Drug Administration’s stance on potential approval of its proposed persistent kidney illness (CKD) drug, Ardelyx will lower one other 102 jobs, in accordance with an SEC Submitting.
The Fremont, CA-based biopharma firm just lately met with the FDA in a Sort A gathering within the hope of pushing ahead with its New Drug Software (NDA) for its hyperphosphatemia drug, tenapanor, which is meant for grownup sufferers identified with persistent kidney illness (CKD) and present process dialysis.
Tenapanor acts within the intestine to regulate serum phosphorous absorption by inhibiting the sodium hydrogen exchanger 3 (NHE3). Sufferers are given a 30 mg pill twice a day to activate this blocking mechanism, with diarrhea recognized as the most typical facet impact.
In July this 12 months, the FDA gave Ardelyx a whole response letter on the NDA, which additionally coated the results of the Sort A gathering. The FDA agreed that the proof offered by Ardelyx was substantial to indicate that tenapanor is efficient in decreasing serum phosphorous, however mentioned the corporate must conduct extra trials to ascertain a “clinically related remedy impact on serum phosphorous or an impact on the scientific consequence thought be attributable to hyperphosphatemia in CKD sufferers on dialysis.”
The CRL didn’t point out something about scientific pharmacology or biopharmaceutics, security, or any associated non-clinical considerations.
“On condition that now we have performed the requisite registration research, which met all major and key secondary endpoints with no security or different recognized points, we proceed to be extraordinarily disenchanted and shocked by the shortage of readability from the FDA on the subsequent steps to resubmit our NDA,” mentioned Mike Raab, president and chief government officer of Ardelyx, in an announcement.
The corporate introduced that it’s implementing a major restructuring plan to “protect money assets and prolong money runway,” together with vital job cuts. Lots of those that have been retained are essential to assist the work and regulatory procedures wanted to lastly achieve approval for tenapanor.
“Whereas a setback for our firm, we consider the delay in approval represents a extra vital hardship for sufferers who’re being denied entry to tenapanor, a much-needed, novel therapeutic different with a special mechanism of motion. We stay devoted to offering these underserved sufferers, of which 77% are unable to keep up goal phosphorus ranges regardless of energetic remedy with presently out there therapies, one other remedy possibility,” added Raab.
Ardelyx introduced its restructuring program on October 12 in response to the FDA’s CRL in July. This system will likely be accomplished by December this 12 months. The job cuts are anticipated to scale back the corporate’s money compensation prices by round $18.1 million per 12 months. Ardelyx has but to obtain a replica of the minutes of the Sort A gathering with the FDA as of this writing.
— to www.pharmalive.com