Sanofi and Regeneron receives FDA priority review for prurigo nodularis

The US Food and Drug Administration (FDA) has accepted priority review of Sanofi and Regeneron’s jointly developed Dupixent (dupilumab) to treat adults with prurigo nodularis.

A decision on the supplemental Biologics License Application (sBLA) is expected from the FDA on 30 September 2022, while additional regulatory filings in other countries are expected in 2022.

Priority reviews are granted by the FDA for therapies that could potentially provide significant improvements in the treatment, diagnosis or prevention of serious diseases.

Prurigo nodularis is a chronic inflammatory skin disease that can cause an intense and extreme itch and skin lesions – also referred to as ‘nodules’ – that can cover most of the body.

For patients, the impact of uncontrolled prurigo nodularis on their quality of life is comparable to other debilitating chronic conditions that can have a negative affect on mental health, social interactions and day-to-day life. Typically, strong topical steroids are prescribed but are often linked to safety risks if used as a long-term treatment.

In the US, there are around 75,000 people who are unable to control their disease with systemic therapy and are most in need of a treatment option.

At present, there are no approved systemic treatments for the condition and Dupixent is the first and only option of its kind to demonstrate positive phase 3 data for the disease.

The positive data from the two pivotal PRIME and PRIME2 trials supports the sBLA, as it assessed the safety and efficacy of Dupixent for those aged 18 years and above with uncontrolled prurigo nodularis.

In both PRIME and PRIME2, the primary and key secondary endpoints were met and showed Dupixent significantly improved disease signs and symptoms versus placebo. This included a considerable reduction in itch and skin lesions, while the safety results gathered from the studies were consistent overall with the existing safety profile of Dupixent in atopic dermatitis.

The potential use of Dupixent as a treatment for prurigo nodularis is currently under clinical development, while its safety and efficacy has not yet been fully assessed by any regulatory authority.