Novartis NVS announced that the FDA has approved a label expansion of IL-17 inhibitor, Cosentyx (secukinumab).
Cosentyx is now approved for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA).
The approval of Cosentyx for the indication of nr-axSpA, which is part of the axial spondyloarthritis (axSpA) disease spectrum, was based on efficacy and safety outcomes from the phase III study, PREVENT. The study evaluated 555 adults with active nr-axSpA who were biologic treatment naïve or had an inadequate response / intolerant to an anti-tumor necrosis factor-α therapy (anti-TNFs). Cosentyx met the primary endpoints achieving statistically significant improvements as compared to placebo in the signs and symptoms of nr-axSpA. Patients treated with Cosentyx showed improvement in both load and without load arms compared to placebo-treated patients at week 16 in health-related quality of life as measured by the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire.
The nr-axSpA is the fourth indication, for which Cosentyx obtained approval in the United States. It is already approved for moderate-to-severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
The drug was also approved by the European Medicines Agency for this indication in April 2020.
Recent label expansions of the drug have fueled sales. Cosentyx sales increased 19% to $930 million in the first quarter of 2020, driven by strong demand in the United States with broad first-line access in all three indications — psoriasis, psoriatic arthritis and AS. In January, Novartis announced the receipt of FDA approval for a label update to include the option for up-titration to a 300mg dose for adults with active AS.
The drug’s demand has been good despite stiff competition from AbbVie’s ABBV Humira, Eli Lilly’s LLY Taltz and Johnson & Johnson’s JNJ Tremfya.
The stock has lost 6.2% in the year so far compared with the industry’s decline of 3.6%
Solid performance of key drugs like Cosentyx and Entresto, and contribution from gene therapy, Zolgensma, has boosted Novartis’ top line in recent times. New launches like Piqray and Beovu should further boost the company’s performance in the upcoming quarters.
However, the FDA has recently approved a label update for ophthalmology drug, Beovu, to include additional safety information regarding retinal vasculitis and retinal vascular occlusion. It remains to be seen the growth trajectory that Beovu takes up following this label update.
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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