Celgene’s psoriasis drug gains FDA approval

Otezla, a first-in-class treatment for plaque psoriasis has been approved in the US.

Celgene’s drug Otezla (apremilast) is an oral, selective inhibitor of phosphodiesterase 4 (PDE4) and gained its first approval in March this year for the treatment of psoriatic arthritis.

The drug may eventually take on established biologics players in both these fields, most notably AbbVie’s market leader Humira, but for now Celgene are promoting the drug as a treatment for patients not responding well to current treatment.

The drug is of strategic importance for Celgene, as it represents part of its plan for diversifying its business beyond its specialist fields of haematology and oncology.

However, analysts are yet to be convinced by trial data that Otezla can challenge the dominance of Humira and Amgen and Pfizer’s Enbrel, with most peak sales forecasts going no higher than $1 billion.

“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,” said Dr. M. Shane Chapman, Section Chief of Dermatology at Dartmouth-Hitchcock Medical Center.

“Because the product labelling does not require routine laboratory monitoring, oral Otezla may be a welcome new option for patients and physicians looking for a different treatment experience.”

“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,” said Scott Smith, president inflammation & immunology for Celgene.

In the company’s large scale ESTEEM studies, the drug produced significant and clinically meaningful improvements in plaque psoriasis, as measured by PASI scores at week 16. Clinical improvement as measured by sPGA scores of clear to almost clear were also demonstrated in both studies.

Observed side effects of Otezla were diarrhoea, nausea, upper respiratory tract infection, tension headache, and headache. More notable are warnings about depression and weigh gain: before starting Otezla, patients are instructed to inform their doctor if they have a history of depression or suicidal behaviour and if these conditions or other mood changes develop or worsen while taking the drug. Patients taking the drug should have their weight checked regularly. Doctors will have to balance these side-effects against the well-known ones seen in the biologics, which include TB and lymphoma.

Fierce competition

Celgene’s drug is entering a fiercely competitive market, with many companies looking to produce a drug to be the ‘next generation’ Humira. Celgene’s drug is not the first oral treatment in the field – Pfizer’s Xeljanz (tofacitinib) was approved for the treatment of rheumatoid arthritis in 2012, but has struggled to gain market share.

Pfizer does, however, have plans to submit Xeljanz in early 2015 for moderate-to-severe chronic plaque psoriasis.

Another anticipated new competitor is Lilly. Just last month the firm unveiled strong phase III results for its ixekizumab, showing it to be superior to Enbrel (etanercept) and placebo on all skin clearance in the disease. Lilly plans to submit its drug to regulators in the first half of 2015.

New entrants to the market will also have to contend with biosimilar versions of the established biologic drugs; Hospira’s Inflectra (infliximab, a copy of Remicade) is already approved in Europe, while Celltrion’s US infliximab biosimilar is awaiting approval.

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