Celgene Wins FDA Approval For New Indication of Otezla
By Lori Clapper
Celgene Corporation announced Tuesday that it received a nod from the U.S. Food and Drug Administration (FDA) for a new indication of its psoriatic arthritis drug Otezla. With this approval, the med will be used in the treatment of plaque psoriasis, a chronic inflammatory disease of the skin resulting from an uncontrolled immune response that affects more than 125 million people globally.
The drug is now set to go up against currently marketed injections, including AbbVie’s Humira, and Amgen’s and Pfizer’s Enbrel, Bloomberg reported.
Dr. M. Shane Chapman, Section Chief of Dermatology at Dartmouth-Hitchcock Medical Center said Otezla is unique in that it doesn’t require routine laboratory monitoring like other treatments, making it a “welcome new option for patients and physicians looking for a different treatment experience.” He added that clinical trials shows that that the pill helped those who aren’t having success with current treatment options.
Otezla was approved based on safety and efficacy results from two multicenter, randomized, double-blind, placebo-controlled studies, ESTEEM 1 and ESTEEM 2, which were conducted in 1,426 adult patients with moderate to severe plaque psoriasis. Data collected from the studies showed significant clinical improvements in plaque psoriasis as measured by PASI scores at week 16 and sPGA scores of clear to almost clear were also demonstrated.
The FDA approved OTEZLA in March 2014 for adults with active psoriatic arthritis. Celgene said it also submitted a New Drug Submission (NDS) for psoriatic arthritis to regulators in Canada in 2013, along with a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe in 2013.
"Psoriasis is a serious autoimmune disorder commonly associated with comorbidities," Randy Beranek, president and CEO, National Psoriasis Foundation, said. "Effectively treating psoriasis is an important part of managing a patient's overall health. Having a new treatment like Otezla is important so patients can have more options and can work closely with their providers to find what works best for them."
The drug is also being studied as a potential treatment for a type of spondylitis, a group of chronic or long lasting diseases also called Spondyloarthritis (SpA), Spondyloarthropathy.
According to Reuters, Celgene estimates that annual Otezla sales will reach $1.5 billion to $2 billion by 2017.