On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps. GlobalData anticipates that this safety update will likely raise physician and regulator vigilance regarding long-term Dupixent use but is unlikely to impact overall prescribing patterns for the product.

Sanofi and Regeneron’s Dupixent had previously been linked to conjunctivitis, an eye condition usually caused by allergies or an infection. This symptom, captured previously in clinical trials for the drug, was typically mild, but it is known to worsen without proper management and care. More recently, the MHRA announced that it had received 479 UK reports of ocular side effects associated with Dupixent use, with 111 of those being considered serious. Of these reports, nine were for ulcerative keratitis, an eye-related condition that directly affects the cornea and can impact a patient’s vision if not properly managed.

These types of more serious events have propelled the MHRA to announce plans to produce new guidance and product information for the management of patients with Dupixent-related eye complications. Other regulators such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have yet to make any announcements with regards to these ocular side effects outside of the already established conjunctivitis issues. However, it is expected that this will put Dupixent and other upcoming pipeline biologics in the allergic disease space more on the radar of regulators.

Despite these concerns, GlobalData anticipates that Sanofi and Regeneron ’s strong positions in the allergic diseases market will be unaffected. Dupixent is an extremely important and effective product in the treatment of severe allergic disease, and GlobalData believes this product will retain its status in current treatment algorithms. For example, in atopic dermatitis, the drug is expected to gross $17.5bn by 2030, outpacing all other agents in the space. The key is that physicians and patients are made aware of the potential for these side effects and that guidelines are put in place to address the issues when they arise.

This will, however, likely trigger Dupixent’s competitors to look more closely at the safety of their products. For example, Leo Pharma ’s Adtralza (tralokinumab), which also inhibits the IL-13 pathway and has been linked to conjunctivitis issues, is also being tracked by the MHRA for any reported adverse events. If the product proves to have a milder safety profile, this could help set this product apart from Dupixent. In addition, depending on clinical trial data, upcoming competitors such as Eli Lilly’s lebrikizumab (which also targets IL-13) and Galderma ’s nemolizumab (which targets IL-31) may be able to use improved adverse event profiles to help differentiate their products.


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