The US Food and Drug Administration (FDA) has issued regulatory approval for Novartis’ (NYSE: NVS) IL-17A-targeting drug Cosentyx (secukinumab) for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa (HS). This approval positions Cosentyx as a new entrant in the HS biologic therapy market, potentially challenging AbbVie’s (NYSE: ABBV) Humira (adalimumab) dominance in the US.
Clinical Evidence and FDA Decision
The FDA’s decision is backed by positive results from two Phase III studies, which demonstrated that both fortnightly and monthly subcutaneous administration of Cosentyx led to a clinical response in a significantly higher proportion of patients compared to those receiving a placebo. These findings underscore the drug’s efficacy in treating this chronic skin condition.
Market Implications and Patient Impact
The approval of Cosentyx for HS marks an important development in the biologic therapy market, offering an alternative treatment option for patients suffering from moderate-to-severe forms of the disease. This move by the FDA could lead to a shift in the treatment landscape, providing patients with more choices and potentially improving outcomes for those with hidradenitis suppurativa.-Fineline Info & Tech
