Valeant's Ortho Dermatologics Says FDA Accepts NDA For IDP-122 Lotion

(RTTNews) - Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (VRX, VRX.TO) announced Wednesday that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application for JEMDEL™1 (halobetasol propionate 0.01%) IDP-122 lotion. The PDUFA action date is set for October 5, 2018.

If approved, JEMDEL will be the first high-potency topical steroid treatment for plaque psoriasis with dosing for as long as eight weeks. In the clinical trials, the most common adverse event was upper respiratory tract infection. JEMDEL was studied for up to eight weeks of use.

"The impact of psoriasis can be devastating for the millions of patients who live with the pain and stigma of this lifelong chronic condition," said Joseph Papa, chairman and CEO, Valeant. "If approved, we believe JEMDEL will be an important option for patients with plaque psoriasis."

Psoriasis is a chronic, painful and frequently life-altering immune-mediated inflammatory skin disease associated with serious comorbidities and substantial impairment of physical and psychological quality of life. More than 75% of patients with moderate-to-severe plaque psoriasis experience significant itching, and greater than 55% report moderate or worse levels of pain.