Korsuva Approved for Chronic Kidney Disease-Associated Pruritus
The approval was based on data from the pivotal phase 3 KALM-1 and KALM-2 trials, as well as data from an additional 32 clinical studies.
Pruritus And Dry Skin
MPR Weekly Dose Podcast Episode 87
This week we have news of the FDA requesting a change to statin prescribing labels, a new vaccine for streptococcus pneumoniae, a new plaque psoriasis cream, a stem cell therapy gets fast tracked as a possible Parkinson disease treatment, and there’s a new treatment approved for Progressive Familial Intrahepatic Cholestasis.
Bylvay Approved for Progressive Familial Intrahepatic Cholestasis
Bylvay is an oral reversible inhibitor of the ileal bile acid transporter.
Sarna Eczema Relief Whipped Foam Now Available
The whipped foam formulation allows for rapid absorption to provide fast relief.
Rapid Relief Restoring Cream Added to AmLactin Product Line
AmLactin® Rapid Relief Restoring Cream is supplied in 12-ounce (340g) jars and costs $24.99.
FDA to Review Difelikefalin for Chronic Kidney Disease-Associated Pruritus
The NDA submission is supported by data from the pivotal phase 3 KALM-1 and KALM-2 trials.
FDA to Review Odevixibat for Progressive Familial Intrahepatic Cholestasis
Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport inhibitor.
Serlopitant Not Statistically Significantly Better Than Placebo in Prurigo Nodularis Studies
Menlo Therapeutics announced topline results from two phase 3 studies of serlopitant for the treatment of pruritus associated with prurigo nodularis.
Tradipitant Misses Primary End Point in Atopic Dermatitis Trial
Vanda Pharmaceuticals announced data from the phase 3 EPIONE study of tradipitant for the treatment of pruritus in atopic dermatitis. The 8-week, multicenter, double-blind, placebo-controlled study evaluated the efficacy of tradipitant, a neurokinin-1 receptor antagonist, in 341 adult patients with atopic dermatitis who presented with severe pruritus. Patients were randomized 1:1 to receive either tradipitant…
Nemolizumab Gets Breakthrough Therapy Status for Prurigo Nodularis
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to nemolizumab (Galderma) for the treatment of pruritus associated with prurigo nodularis. Prurigo nodularis is a rare skin disease that is characterized by the formation of hard, itchy nodules on the skin. It is commonly associated with intense itching that may lead to severe…
