Pfizer's Crisaborole Ointment Receives NMPA Approval for New Indication in China

On August 3, the official website of the National Medical Products Administration announced that Pfizer's crisaborole ointment (trade name: Staquis) has been approved for marketing with a new indication, presumably for the treatment of atopic dermatitis in children aged 3 months and above and adults.

Crisaborole is a small molecule, non-hormonal, non-steroidal anti-inflammatory topical phosphodiesterase 4 (PDE-4) inhibitor developed by Anacor. In May 2016, Pfizer acquired the company for $5.2 billion and obtained this drug. In December of the same year, crisaborole was approved by the FDA for marketing, becoming the first prescription drug for atopic dermatitis to be approved in 10 years, as well as the first non-steroidal topical drug that inhibits phosphodiesterase 4 in the skin.

In April 2020, the FDA approved Pfizer's supplemental new drug application for crisaborole ointment, expanding the age limit for pediatric patients with mild to moderate atopic dermatitis from 2 years old to as young as 3 months. This is also the first 100% non-steroidal topical prescription medication approved by the FDA for patients as young as 3 months.

In July 2020, crisaborole ointment was approved for marketing in China to treat mild to severe atopic dermatitis in patients aged 2 years and above. It was included in the national "Second Batch of Overseas New Drugs Urgently Needed in Clinical Practice," and the approval process took less than six months from submission of the marketing application.

According to the PharmaGO database by PharmCube, the Phase III clinical trials of Crisaborole Ointment for children (2 years and above) and adult patients with mild to moderate atopic dermatitis in China and Japan, as well as the Phase III clinical study for long-term maintenance treatment to reduce recurrence in pediatric and adult patients with mild to moderate atopic dermatitis, have both been completed.

Atopic Dermatitis, Commonly Known as Eczema

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