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Regulatory Focus™ > News Articles > 2020 > 9 > FDA Roundup: Sogroya, Onureg, Winlevi

FDA Roundup: Sogroya, Onureg, Winlevi

Posted 02 September 2020 | By Renee Matthews 

FDA Roundup: Sogroya, Onureg, Winlevi

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).

New approvals
Sogroya okayed as weekly therapy for adult growth hormone deficiency
Novo Nordisk’s Sogroya (somapacitan-beco injection) has been approved as the first once-weekly, human growth hormone (hGH) therapy for adults with growth hormone deficiency.
Until now, the only treatment option for patients with the disorder has been a daily formulation of the hormone. The deficiency is caused by inadequate growth hormone secretion from the anterior pituitary gland.
Sogroya was approved based on findings of effectiveness in a randomized, double-blind, placebo-controlled trial in 300 patients with hGH deficiency. Patients were randomized to receive weekly Sogroya shots or placebo, or daily somatropin, an approved growth hormone. Effectiveness of Sogroya was determined by the percentage change in truncal fat, which the growth hormone regulates.
After 34 weeks of treatment, truncal fat was reduced by an average 1.06% in patients taking weekly Sogroya, compared with an average increase of 0.47% in weekly placebo patients. Patients in the daily somatropin group had a decrease of 2.23% in truncal fat. Patients on weekly Sogroya and daily somatropin showed similar clinical improvement in other study endpoints.
Onureg gets the nod as continued therapy for first-remission AML
Celgene’s Onureg (azacitidine tablet) has received approval for continued treatment of acute myeloid leukemia (AML) in patients who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) but are not able to continue with curative therapy. It is the first approved therapy for continued treatment of this group of patients.
Approval was based on favorable efficacy findings with Onureg in QUAZAR AML-001, a multicenter, randomized, double-blind, placebo-controlled trial in 472 patients who had achieved CR or CRi with intensive induction chemotherapy. Patients were randomized to receive oral Onureg or placebo for 14 consecutive days of each 28-day cycle during the study. The primary study Overall survival was the main measure of efficacy.
Median OS was 24.7 months (95% confidence interval, 18.7-30.5) for patients treated with Onureg, compared with 14.8 months (95% CI, 11.7-17.6) for those receiving placebo (hazard ratio, 0.69; 95% CI, 0.55-0.86; P = .0009). A sub-analysis showed consistency in the OS benefit for both CR and CRi patients.
Onureg is designated an orphan drug and its new drug application received priority review. In May this year, the European Medicines Agency validated a marketing authorization application for the same indication.
Winlevi approved for treating acne in adolescent, adult patients
Cassiopea’s Winlevi (clascoterone cream 1%) has received approval as a first-in-class, nonantibiotic topical treatment of acne vulgaris in male and female patients aged 12 years or older.
The approval marks the first in 40 years for an acne therapy with a new mechanism of action. Winlevi is an androgen receptor inhibitor. Its MOA is not fully understood, but it is thought to interfere with androgen hormone activity, which drives sebum production and inflammation in acne.
“This game-changing topical drug offers a nonantibiotic approach to people with acne, by targeting the androgen receptors directly in the skin. It fills a longstanding gap in acne therapy,” said Michael Gold, MD, investigator and medical director at Gold Skin Care Center and Tennessee Clinical Research Center in Cassiopea’s announcement of the approval.
Results from two randomized, 12-week, phase 3 studies in 1,440 patients showed that patients treated with Winlevi had significant reductions in noninflammatory and inflammatory lesion counts from  baseline, compared with patients treated with vehicle cream. Safety findings for the therapy were favorable.


Tags: FDA, US

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