Sanofi, Regeneron to seek Dupixent approval for bullous pemphigoid after positive phase 3 study

Sanofi and Regeneron's acclaimed anti-inflammatory drug Dupixent is making significant strides. On the same day the companies released positive data from a study in chronic spontaneous urticaria (CSU) and a new analysis in chronic obstructive pulmonary disease (COPD), they also announced promising results from a pivotal trial for a rare skin condition known as bullous pemphigoid (BP). These findings are expected to bolster another regulatory filing later this year.

In a 106-patient phase 3 ADEPT study, patients with BP treated biweekly with 300 mg of Dupixent achieved sustained disease remission at a rate five times higher (20%) compared to the placebo group (4%). According to Sanofi's press release, sustained remission was defined as complete clinical remission after discontinuing standard oral corticosteroids (OCS) by week 16, without relapses or the need for additional rescue therapy over the 36-week trial period. Dupixent also outperformed placebo on secondary measures, including reduced disease severity and significant reduction in itchiness.

Bullous pemphigoid is a chronic, relapsing disorder marked by painful skin lesions, itching, and blisters, which can lead to infection, particularly affecting individuals aged 60 to 80. Dietmar Berger, M.D., Ph.D., Sanofi’s chief medical officer and global head of development, emphasized the pressing need for new treatments for this challenging condition, which currently relies on oral and topical corticosteroids and immunosuppressants—options that are not only ineffective but also risky, especially for the elderly. Berger highlighted the potential of Dupixent to revolutionize the treatment landscape for BP, given its consistent safety profile across various dermatological indications.

In the studied elderly population, the incidence of adverse events was similar for both the Dupixent and placebo groups, standing at 96%. However, certain adverse events, such as peripheral edema, blurred vision, and asthma, were more frequent in the Dupixent group. Importantly, there were no deaths related to adverse events in the Dupixent group, whereas two deaths occurred in the placebo group.

In addition to the ADEPT trial, another phase 3 study assessed Dupixent's efficacy in adults with severe chronic pruritus of unknown origin (CPUO). Although this trial did not meet its primary endpoint, it did show favorable numerical improvements. Dupixent had previously received orphan drug designation from the FDA for BP, and the positive results from the ADEPT trial are expected to support regulatory approval efforts globally, starting with the FDA. If successful, Dupixent would become the first targeted treatment for BP in both the U.S. and Europe.

The BP findings came on the same day Sanofi shared positive results in CSU, following a prior FDA rejection for that indication. The partners plan to file for a label expansion for CSU as well. Additionally, Sanofi announced that a pooled analysis of two phase 3 studies reinforced Dupixent's significant clinical benefits in COPD. The FDA is expected to make a decision regarding Dupixent's potential approval for COPD by September 27, following an earlier delay.

Overall, these developments highlight Dupixent's potential to significantly impact the treatment of multiple challenging conditions, reaffirming its role in the evolving landscape of inflammatory disease management.

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