FDA Granted Fast Track Designation for Lebrikizumab

| By | Fast Track, FDA
0
107

Dermira, Inc., a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for lebrikizumab, its novel, investigational treatment being evaluated for patients with moderate-to-severe atopic dermatitis.

Fast Track is a designation granted by the FDA intended to facilitate the drug development process and expedite the review of therapies to treat serious conditions and fill an unmet medical need, including by demonstrating an advantage over currently available therapy. The goal of the Fast Track process is to ensure important new treatments reach patients as quickly as possible.

“We are pleased that the FDA granted lebrikizumab its Fast Track designation and recognizes the unmet need for patients living with moderate-to severe atopic dermatitis and the potential for lebrikizumab to offer a treatment for this serious condition,”

said Tom Wiggans, chairman and chief executive officer of Dermira.

“This Fast Track designation puts us one step closer to potentially delivering a new therapeutic option more quickly to patients should the results from earlier Phase 2 studies be confirmed in the ongoing Phase 3 studies assessing the safety, efficacy and tolerability of the investigational therapy.”

Lebrikizumab is currently being evaluated in two Phase 3 studies, ADvocate 1 and ADvocate 2, to confirm its safety and efficacy in adolescent and adult patients, ages 12 years and older, with moderate-to-severe atopic dermatitis.

SOURCE: businesswire.com
SHARE
GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.