Novartis Scores FDA Green Light for Game-Changing Intravenous Version of Cosentyx

In a significant development, the FDA gave its green light on Friday to an intravenous version of Novartis’ IL-17A antagonist, Cosentyx (secukinumab), for the treatment of rheumatic diseases. This approval expands the treatment options for conditions like ankylosing spondylitis (AS), psoriatic arthritis (PsA), and non-radiographic axial spondyloarthritis (nr-axSpA), which were previously only treated with subcutaneous injections of Cosentyx.

Cosentyx, with its novel intravenous delivery method, marks a groundbreaking advancement in targeting and inhibiting IL-17A. It now stands as the sole non-TNF-α intravenous therapy for these conditions, according to Novartis.

This new administration route is expected to benefit a significant number of patients who either find self-injections uncomfortable or prefer to receive treatments at their healthcare provider’s office, as highlighted by Philip Mease, a clinical professor at the University of Washington School of Medicine.

Mease noted, “The approval of Cosentyx as an IV formulation is an important milestone for patients because it expands the treatment options available to them with a different mechanism of action than existing biologic IV therapies.”

Cosentyx operates as a fully human monoclonal antibody, honing in on and inhibiting the IL-17A cytokine. By doing so, it quells the overactive inflammatory pathways commonly associated with rheumatic diseases.

Cosentyx initially received FDA approval back in January 2015 for moderate-to-severe plaque psoriasis, and since then, it has become a cornerstone of Novartis’ commercial success. In 2022, this immunological asset generated nearly $4.8 billion in net sales, reflecting a 5% growth at constant currencies. Novartis credited a substantial part of its overall growth last year to the stellar performance of several products, with Cosentyx leading the way.

This latest FDA approval comes on the heels of a series of clinical triumphs for Novartis, as the company pushes forward with numerous late-stage assets on the regulatory front. Just last week, Novartis announced its intentions to seek FDA accelerated approval for its complement inhibitor iptacopan in IgA nephropathy (IgAN) in 2024, following strong Phase III results in the APPLAUSE-IgAN study.

In late September, Novartis celebrated another Phase III victory, this time with its radioligand therapy Lutathera (lutetium Lu 177 dotatate), which showed significant improvements in progression-free survival for patients with advanced gastroenteropancreatic neuroendocrine tumors when used as a first-line treatment. The company has indicated plans to discuss these results with regulatory authorities.

Novartis is also in the midst of a substantial corporate transformation, including the confirmed and approved spin-off of Sandoz, as well as a cost-saving initiative aimed at trimming at least $1 billion in expenses by 2024, which includes significant workforce reductions.

Leave a Comment