Xeris Cushing’s syndrome drug Recorlev bags US approval

USA – According to a press release by Xeris, the FDA has approved the steroidogenesis inhibitor Recorlev, (levoketoconazole) for adults with Cushing’s syndrome for whom surgery is not an option or has not been curative.

Levoketoconazole was approved after positive efficacy and safety results from the multinational phase 3 SONICS and LOGICS studies evaluating levoketoconazole as a potential treatment for endogenous hypercortisolemia in adults with Cushing’s syndrome.

Endogenous Cushing’s disease is caused by a benign tumor in the pituitary gland, which causes the body to produce excessive cortisol, resulting in a variety of devastating physical and emotional symptoms for patients over time.

According to the company, the drug significantly reduced and normalized mean urinary free cortisol concentrations in the SONICS study without increasing the dose. The LOGICS trial confirmed the drug’s efficacy and safety.

Despite the recent approval of novel therapies, Cushing’s disease management remains difficult. If left untreated, the disorder is associated with significant comorbidities and has a high mortality rate.

Endogenous Cushing’s syndrome, caused by chronic hypercortisolism, is uncommon, with the National Institute of Diabetes and Digestive and Kidney Diseases estimating that 40 to 70 people per million are affected worldwide.

Cushion’s is a potentially fatal endocrine disease, and patients frequently experience years of symptoms before receiving an accurate diagnosis, according to the company. Following a diagnosis, they are given a limited number of effective treatment options.

Following the approval, the company’s “experienced endocrinology-focused commercial organization can begin rapidly working to help address the needs of Cushing’s syndrome patients in the U.S. who are treated with prescription therapy,” Xeris CEO Paul R. Edick said in a statement.

In addition to the upcoming Recorlev launch, Xeris also markets Gvoke, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, and Keveyis, a therapy for primary periodic paralysis, are the company’s two products.

The Company develops and commercializes its products using its non-aqueous formulation technology platforms, XeriSol and XeriJect.

The XeriSol formulation technology is ideal for peptides and small molecules that are difficult to formulate.  

Similarly, the XeriJect formulation technology is appropriate for drugs and biologics that contain large molecules such as proteins, monoclonal antibodies, and vaccines.

In October, the company collaborated with Merck to help reformulate some of the New Jersey-based pharmaceutical giant’s monoclonal antibody drugs.

Liked this article? Sign up to receive our regular email newsletters, focused on Africa and World’s healthcare industry, directly into your inbox. SUBSCRIBE HERE

Related posts

Leave a Comment

This site uses Akismet to reduce spam. Learn how your comment data is processed.