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Apremilast: first global approval.

Raewyn M Poole¹, Anita D Ballantyne

¹Adis, Auckland, New Zealand.

|May 7, 2014

Summary

This summary is machine-generated.

Apremilast, a PDE-4 inhibitor, is approved for active psoriatic arthritis. This oral medication offers a new treatment option for adults with this condition.

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Area of Science:

Pharmacology
Immunology
Dermatology

Background:

Apremilast is an oral small molecule inhibitor of phosphodiesterase-4 (PDE-4).
It is being developed for inflammatory conditions including psoriatic arthritis, psoriasis, and rheumatoid arthritis.
The drug targets intracellular cyclic adenosine monophosphate (cAMP) levels.

Purpose of the Study:

To summarize the key developmental milestones of apremilast.
To highlight the regulatory pathway leading to its first approval.
To provide an overview of apremilast's journey to market for psoriatic arthritis.

Main Methods:

Review of developmental and regulatory submissions for apremilast.
Analysis of clinical trial data leading to efficacy and safety assessments.
Tracking of regulatory agency reviews and approvals.

Main Results:

Apremilast has achieved its first global approval for active psoriatic arthritis in adults in the USA.
Regulatory submissions are under review in Canada and Europe for psoriatic arthritis.
Filings for plaque psoriasis treatment have also been submitted in the USA and Europe.

Conclusions:

Apremilast represents a significant advancement in the oral treatment of psoriatic arthritis.
The drug's development highlights a successful progression through regulatory channels.
Further regulatory reviews are anticipated for apremilast in psoriatic arthritis and plaque psoriasis.