Key tests for blockbuster Novartis drug failure hope to expand its use to rare vascular disorders
Novartis is in competition to expand its blockbuster explosives Cosentyx into autoimmune diseases, its only biotherapeutic option is the old Roche drug and the biosimilar that follows it.
Novartis drugs are evaluated as a potential treatment for giant cell arteritis (GCA), the most common form of systemic vasculitis. Vasculitis is an autoimmune disease that causes inflammation of the blood vessels. In GCA, this inflammation affects arteries in the head and neck. This rare disease often affects people aged 50 and older, and can lead to vision loss and life-threatening aortic aneurysms.
The standard treatment for GCA is high doses of corticosteroids for one month, followed by a gradual reduction of steroids over the subsequent months. However, risks of long-term use of steroids include susceptibility to infection, hypertension and osteoporosis.
Cosentyx is not developed to replace steroids, but is designed to reduce the amount of steroids needed by patients with GCA. The drug is an antibody designed to inhibit interleukin 17a, a signaling protein involved in inflammation in a variety of autoimmune diseases.
Roche’s Actemra already enables steroid cells to treat GCA by blocking a protein called IL-6. The Roche antibody drug added GCA to its label in 2017, but it no longer has patent protection and several biosimilars are taking over its market share. Abbvie’s Rinvoq can be used to narrow down the use of steroids in GCA, a new indicator added on its tag in April. Rinvoq is an oral small molecule inhibitor of JAK protein. The entire JAK inhibitor causes black box warnings about cancer and cardiovascular complications.
Cosentyx’s Phase 3 test in GCA evaluated the drug in combination with a 26-week steroid taper. This regimen was compared with a placebo plus 52 weeks of steroid taper. Novartis said that in preliminary results, Cosentyx did not show a statistically significant improvement in sustained remission during Week 52 compared to the placebo unit before the Independence Day holiday. In the secondary trial targets that measured cumulative steroid doses and steroid-related toxicity, Cosentyx had a numerical better outcome to beat the statistically significant placebo group.
Novartis said the safety of Cosentyx in the GCA study, called Gcaptain, is consistent with the known drug profile. The most common adverse reactions used with Cosentyx include nasopharyngitis, diarrhea, and upper respiratory tract infections. Novartis said it will complete a complete evaluation of the 3-stage data in the GCA and share the results later.
“Although Gcaptain’s Phase 3 results do not replicate the positive results observed in the Phase 2 trial, we remain committed to continuing to advance science and deepen our understanding of immune-mediated diseases,” Novartis Chief Medical Officer Shreeram Aradhye said in a prepared statement.
Cosentyx was first approved in 2015 for the treatment of plaque psoriasis. Since then, the drug has received additional FDA approval in ankylosing spondylitis, psoriatic arthritis, non-radio-axial spondylitis and Hidradenitis puratrativa. Cosentyx is Novartis’ best-selling immunology product. Of all signs of approval for the drug, revenue in 2024 accounted for $6.1 billion, up 23% from the previous year, according to Novartis annual report. Cosentyx still has another chance to expand its label. Phase 3 tests in polymyalgia rheumatoid arthritis are underway.
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