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Novartis Gets Positive CHMP View for Cosentyx Label Expansion


Novartis NVS announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the label expansion of IL-17 inhibitor, Cosentyx (secukinumab).

The CHMP gave a positive opinion for Cosentyx for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6-18 years.

The positive CHMP opinion was based on two phase III studies, which showed that Cosentyx provided fast and strong skin clearance and significant improvement in the quality of life with a favorable safety profile for up to 52 weeks.

Approximately half of the children with moderate-to-severe plaque psoriasis treated with a low dose of Cosentyx reported complete relief from symptom burden of psoriasis on their quality of life by as early as week 12.

A tentative approval in Europe will boost sales of the drug.

Cosentyx’s 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 approved indications — psoriasis, psoriatic arthritis and ankylosing spondylitis (AS).

Earlier this month, the FDA also approved a label expansion of Cosentyx for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA). The drug was also approved by the EMA for this indication in April 2020. These label expansions should further propel sales of the drug.

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.

Cosentyx has delivered a stellar performance in the last couple of years despite stiff competition from AbbVie’s ABBV Humira, Eli Lilly’s LLY Taltz and Johnson & Johnson’s JNJ Tremfya.

In fact, the drug has been a key growth driver for Novartis in recent times.

The stock has lost 5.7% in the year so far compared with the industry’s decline of 2.4%.

Solid performance of key drugs like Cosentyx and Entresto, and contribution from gene therapy, Zolgensma, have boosted Novartis’ top line in recent times and enabled it to combat generic competition for key drugs and a slowdown in the generics business. 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. The growth trajectory that Beovu takes up following this label update has yet to be seen.

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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