Galderma S.A. will launch its first-ever therapeutic biologic in 2024, assuming US Food and Drug Administration approval is granted later this year, and presented long-term data at the American Academy of Dermatology (AAD) meeting in San Diego that it believes will make the case for preferential use of its IL-31 receptor alpha inhibitor nemolizumab in prurigo nodularis (PN) and in certain Dupixent (dupilumab)-treated and -naïve patients with atopic dermatitis (AD).
Key Takeaways
-
Galderma reported positive longer-term data for its IL-31 inhibitor nemolizumab in prurigo nodularis (PN) and atopic dermatitis (AD) that it believes differentiate the drug, including versus market leader Dupixent (dupilumab).
-
Applications for approval of nemolizumab in PN and AD have been accepted for review in the US and EU, with the first approval expected this year for PN in the US, followed by AD in the US
The private Swiss company, which announced on 6 March that it plans to go public on the SIX Swiss Exchange, has filed nemolizumab for approval in both indications in the US and the EU and said on 14 February that the FDA accepted its biologic license applications for review, granting priority review for the BLA seeing approval to treat PN, an indication for which the agency previously granted a breakthrough therapy
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Scrip for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?
