Amryt Pharma To Submit Formal Dispute Resolution Request For Oleogel-S10 NDA

Biopharmaceutical company Amryt Pharma plc (AMYT) announced Friday that the company plans to submit a Formal Dispute Resolution Request (FDRR) for the company's New Drug Application (NDA) for Oleogel-S10 (Filsuvez), for the treatment of the cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa (EB).

EB is a rare, genetic skin disease characterized by extremely fragile skin that blisters and tears from minor friction or trauma and for which there are no approved treatment options in the US.

Amryt recently had a Type A meeting with the US Food and Drug Administration (FDA) to discuss the issues raised in the Complete Response Letter (CRL) received in February 2022 relating to Amryt's NDA for Oleogel-S10.

Following this meeting, Amryt plans to proceed to the Formal Dispute Resolution pathway in the FDA's Center for Drug Evaluation and Research (CDER) by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
American Honda Motor Co, Inc. has recalled about 2,900 units of 2022 model year Honda TRX90X All-Terrain Vehicles (ATVs) sold in the United States for possible crash and injury hazard, according to a statement issued by the U.S. Consumer Product Safety Commission or CPSC. The Laundress, a unit of Conopco Inc. d/b/a Unilever, is recalling around 8 million laundry and household cleaning products citing risk of exposure to bacteria, U.S. Consumer Product Safety Commission. The recall involves Laundress laundry detergent, fabric conditioner and other cleaning products. Tesla Inc. has delivered its first Semi, a heavy-duty electric truck, to its customer PepsiCo Inc. during an event at its Nevada Gigafactory. The delivery of 500-mile fully electric Semi truck comes five years after the launch of the truck's prototype in 2017. During Thursday night's Semi Delivery Event at Tesla's Sparks, Nevada factory, CEO Elon Musk, with Dan Priestly, ...
Follow RTT