Recorlev Approved to Treat Endogenous Hypercortisolemia in Cushing Syndrome
The approval was based on data from two phase 3 studies that evaluated Recorlev in 166 adults with endogenous Cushing syndrome.
Pituitary Disorders
Skytrofa, a Once-Weekly Therapy for Pediatric Growth Hormone Deficiency, Now Available
The approval was based on data from the phase 3 heiGHt trial, which compared Skytrofa to somatropin in 161 treatment-naïve, prepubertal patients with growth hormone deficiency.
Skytrofa Approved as Once-Weekly Growth Hormone Deficiency Therapy
The approval was based on data from the phase 3 heiGHt trial that assessed Skytrofa in 161 treatment-naïve, prepubertal patients with growth hormone deficiency.
Levoketoconazole Under Review for Endogenous Cushing Syndrome
The NDA submission includes data from the phase 3 SONICS and LOGICS studies that evaluated levoketoconazole in adults with endogenous Cushing syndrome.
Once-Weekly Somatrogon Reduces Treatment Burden in Children With GHD
The C0311002 study compared the patient perception of treatment burden with use of somatrogon to somatropin in 87 children aged 3 to 17 years with GHD.
FDA Approves Sogroya, a Once-Weekly Growth Hormone Deficiency Therapy
Sogroya is administered by subcutaneous injection one time each week.
Mycapssa, an Oral Therapy for Acromegaly, Now Available
Mycapssa is an oral somatostatin analogue.
Nasal Sprays Containing Desmopressin Recalled Due to Superpotency
One nonfatal adverse event has been reported during the timeframe the affected product was distributed.
First Oral Somatostatin Analogue Approved for Acromegaly
The FDA has approved Mycapssa® (octreotide; Chiasma) capsules for the long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
Isturisa Now Available for Treatment of Patients With Cushing Disease
Recordati Rare Diseases, Inc. announced the availability of Isturisa® (osilodrostat) tablets for the treatment of adults with Cushing disease for whom pituitary surgery is not an option or has not been curative. Isturisa is a cortisol synthesis inhibitor that works by blocking the enzyme 11-beta-hydroxylase, which is responsible for the final step of cortisol biosynthesis…
