Apremilast is under clinical development by Amgen and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Apremilast’s likelihood of approval (LoA) and phase transition for Bullous Pemphigoid took place on 18 Feb 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

In addition, the same event on 18 Feb 2022 decreased Apremilast’s LoA and PTSR for Hidradenitis Suppurativa, decreased PTSR for Prurigo, and decreased PTSR for Vitiligo.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Apremilast Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Apremilast overview

Apremilast (Otezla) is a musculoskeletal system agent. It is formulated as a film-coated tablets, tablets for oral route of administration. Otezla is indicated for the treatment of adult patients with active psoriatic arthritis. It is also indicated in adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Otezla used alone or in combination with disease-modifying antirheumatic drugs for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or were an intolerant to previous DMARD therapy and in pediatric patients, indicated for the treatment of chronic plaque psoriasis moderate to severe in adult patients who have not responded, who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet type A PUVA), and for the treatment of adult and pediatric patients with oral ulcers associated with Behçet’s Disease.

It is under development for the treatment of atopic dermatitis (atopic eczema),prurigo, hidradenitis suppurativa, vitiligo, bullous pemphigoid, acne vulgaris, plaque psoriasis (psoriasis vulgaris), psoriasis, psoriatic arthritis, behcet disease.

It was also under development for gouty arthritis, discoid lupus erythematosus (DLE), sarcoidosis, genito urinary system and sex hormones, rosacea, osteoarthritis, crohn's disease, rheumatoid arthritis, asthma, pruritus, ankylosing spondylitis, ulcerative colitis, canker sores, covid-19 and erosive oral lichen planus.

Amgen overview

Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines in six focused disease areas including cardiovascular diseases, oncology/hematology, inflammation, bone health, neurological disorders and nephrology. The company develops products using advanced human genetics to unravel the difficulties of disease and understand the fundamentals of human biology. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels such as print, television and online media. Amgen is headquartered in Thousand Oaks, California, the US.

Quick View Apremilast LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Apremilast
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Dermatology
  • Gastrointestinal
  • Genito Urinary System And Sex Hormones
  • Immunology
  • Infectious Disease
  • Mouth and Dental Disorders
  • Musculoskeletal Disorders
  • Ophthalmology
  • Respiratory
Key Developers
  • Sponsor Company: Amgen
  • Originator: Celgene
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.