FDA Roundup: First Treatment for Hypoparathyroidism, Disposable CGM Approval

FDA Approves First Treatment for Hypoparathyroidism in Adults

The FDA approved palopegteriparatide (Yorvipath) for the treatment of hypoparathyroidism in adults. The approval was based on data from a clinical trial package, which included the phase 2 PaTH Forward and phase 3 PaTHway trials. In the phase 3 trial, palopegteriparatide—which was developed as TransCon PTH—demonstrated significant and sustained improvements in renal function in adults with chronic hypoparathyroidism. The treatment was also seen to be generally well tolerated.

FDA Approves First Monoclonal Antibody to Treat Prurigo Nodularis

The FDA has approved nemolizumab (Nemluvio) for the treatment of prurigo nodularis in adult patients. The approval of nemolizumab was based on data from the phase 3 OLYMPIA 1 (NCT04501666) and OLYMPIA 2 (NCT04501679) clinical trials, in which the therapy met its primary endpoints of an improvement of 4 or greater in weekly average peak Pruritus Numeric Rating Scale at week 16 and an Investigator Global Assessment success at week 16.

FDA Approves Medtronic’s Disposable CGM

The FDA approved a new disposable continuous glucose monitor (CGM) from medical device company Medtronic. The Simplera is an all-in-one CGM that is half the size of the company’s previous devices, which allows for easier insertion and a simplified wear experience without the need for overtape. It is meant to be used as part of a smart multiple daily injection system, which features Medtronic’s smart insulin pen InPen and the Simplera Sync sensor.

FDA Approves Seladelpar for Primary Biliary Cholangitis

The FDA granted accelerated approval to seladelpar (Livdelzi) for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA, Gilead announced in a release.¹ The approval was based on data from the phase 3 RESPONSE trial, in which 62% of patients who received the therapy achieved the primary endpoint of composite biochemical response at month 12.

First FDA-Approved Digital Therapeutic to Treat Depression Now Available in App Stores

The first digital therapeutic to receive FDA approval for the treatment of major depressive disorder is now available for download from mobile application stores. Rejoyn, which was developed by Otsuka Pharmaceutical and Click Therapeutics, is accessible only with a prescription from a health care provider. Patients with a prescription can receive an access code from BlinkRx, a digital pharmacy that is the exclusive provider of the therapeutic program.

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References

1. Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by U.S. FDA. News Release. Gilead. August 14, 2024. Accessed August 15, 2024. https://www.gilead.com/news-and-press/press-room/press-releases/2024/8/gileads-livdelzi-seladelpar-granted-accelerated-approval-for-primary-biliary-cholangitis-by-us-fda