Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US-based biotechnology firm Celgene has received approval from the US Food and Drug Administration (FDA) for its oral, selective inhibitor of phosphodiesterase 4 (PDE4) Otezla (apremilast) to treat patients with moderate to severe plaque psoriasis.
Subscribe to our email newsletter
More than 125 million people worldwide are affected by psoriasis, a chronic inflammatory disease of the skin resulting from an uncontrolled immune response.
The FDA approval was primarily based on safety and efficacy results from two multi-center, randomized, double-blind, placebo-controlled studies ESTEEM 1 and ESTEEM 2.
These trials were carried out in adult patients with moderate to severe plaque psoriasis: body surface area (BSA) involvement of =10%, static Physician Global Assessment (sPGA) of =3, Psoriasis Area and Severity Index (PASI) score =12, and candidates for phototherapy or systemic therapy.
Dartmouth-Hitchcock Medical Center section chief of Dermatology Dr Shane Chapman said Otezla offers an important new treatment option for patients whose symptoms are not adequately improving with their current treatments.
"In clinical trials, Otezla reduced redness, thickness, and scaliness of plaques in patients with moderate or severe plaque psoriasis," Chapman said.
"Because the product labeling does not require routine laboratory monitoring, oral Otezla may be a welcome new option for patients and physicians looking for a different treatment experience."
The safety of Otezla was evaluated in 1,426 patients from three clinical trials and the side effects observed were diarrhea, nausea, upper respiratory tract infection, tension headache and headache.
Celgene Inflammation & Immunology president Scott Smith said Otezla offers a valuable treatment option for a spectrum of plaque psoriasis patients – patients who are treatment-naïve as well as patients who are treatment-experienced, including those previously treated with biologic agents or conventional systemic agents.
"The FDA approval of Otezla for plaque psoriasis, together with the previous approval for psoriatic arthritis, reflects Celgene’s commitment to extending the reach of our research and science in an effort to improve the lives of people worldwide living with chronic inflammatory diseases," Smith said.
Image: The FDA approval of Celgene’ Otezla was based on safety and efficacy results from two multi-center trials ESTEEM 1 and ESTEEM 2.Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net