Clascoterone, sold under the brand name Winlevi, is an antiandrogen medication which is used topically in the treatment of acne. It is also under development in a higher concentration for the treatment of androgen-dependent scalp hair loss, under the brand name Breezula. The medication is used as a cream by application to the skin, for instance the face and scalp.Clascoterone is an antiandrogen, or antagonist of the androgen receptor (AR), the biological target of androgens such as testosterone and dihydrotestosterone. It shows minimal systemic absorption when applied to skin.The medication, developed by Cassiopea and Intrepid Therapeutics, was approved by the US Food and Drug Administration (FDA) for acne in August 2020. The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. Medical uses
Clascoterone is indicated for the topical treatment of acne vulgaris in females and males age 12 years and older. It is applied to the affected skin area in a dose of 1 g cream (or 10 mg clascoterone) twice per day, once in the morning and once in the evening. The medication should not be used ophthalmically, orally, or vaginally.Two large phase 3 randomized controlled trials evaluated the effectiveness of clascoterone for the treatment of acne over a period of 12 weeks. Clascoterone decreased acne symptoms by about 8 to 18% more than placebo. The defined treatment success endpoint was achieved in about 18 to 20% of individuals with clascoterone relative to about 7 to 9% of individuals with placebo.
Recombinant factor VIIa also known as eptacog alfa (INN), and sold under the brand name NovoSeven among others, is a form of blood factor VII that has been manufactured via recombinant technology. It is administered intravenously (IV). Medical uses
NovoSeven is approved for use in the United States and is indicated for the treatment of bleeding episodes and for the prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia.NovoSeven RT is approved in the United States and is indicated for the treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmanns thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets and for the treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia.Sevenfact [coagulation factor VIIa (recombinant)-jncw] is approved for use in the United States and is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents twelve years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies).As of 2012, recombinant factor VIIa is not supported by the evidence for treating most cases of major bleeding. There is a significant risk of arterial thrombosis with its use and thus, other than in those with factor VII deficiency, it should only be given in clinical trials.