Breakthrough Anti-cancer Drug Candidates Targeting Potential Best-in-class Therapies for 2018 - Seite 3

Valeant Pharmaceuticals International Inc. (NYSE: VRX) earlier in the week, Ortho Dermatologics, a division of Valeant Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application for JEMDEL™1 (halobetasol propionate 0.01%) (IDP-122) lotion with a PDUFA action date of Oct. 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. "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 C. Papa, Chairman and CEO, Valeant. "If approved, we believe JEMDEL will be an important option for patients with plaque psoriasis."

Pfizer Inc. (NYSE: PFE) recently announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The Phase 3 program for PF-04965842 initiated in December and is the first trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program. "Achieving Breakthrough Therapy Designation is an important milestone not only for Pfizer but also for patients living with the often devastating impact of moderate-to-severe atopic dermatitis, their providers and caregivers," said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. "We look forward to working closely with the FDA throughout our ongoing Phase 3 development program with the hope of ultimately bringing this important new treatment option to these patients."

DBV Technologies S.A. (NASDAQ: DBVT) recently announced that the U.S. Food and Drug Administration (FDA) has agreed that the available efficacy and safety data for Viaskin Peanut supports the submission of a Biologics License Application (BLA) for the treatment of peanut allergy in children four to 11 years of age. The FDA provided written responses to the clinical pre-BLA meeting package submitted by the Company, which reflect agreement on the content of the clinical module of the BLA for Viaskin Peanut. DBV remains on track to submit its BLA in the second half of 2018. "We are pleased with this positive step forward in our progress towards potential approval of Viaskin Peanut, and appreciate the feedback we received from the FDA supporting submission of our BLA," said Dr. Pierre-Henri Benhamou, Chairman & Chief Executive Officer of DBV Technologies.