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Novartis (NVS) Cosentyx Gets Positive CHMP Opinion for JIA

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Novartis NVS has announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) adopted a positive opinion for the label expansion of blockbuster arthritis drug Cosentyx (secukinumab).

CHMP recommended the approval of the drug used alone or in combination with methotrexate, in the juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in patients six years of age and older whose disease has responded inadequately to, or who cannot tolerate conventional therapy.

The positive CHMP opinion is based on data from the phase III JUNIPERA study, a 2-year, three-part, double-blind, placebo-controlled, randomized withdrawal study that enrolled 86 children and adolescents aged 2–18 years with a confirmed diagnosis of ERA or JPsA according to a modified International League of Associations for Rheumatology classification criteria.

The study showed a longer time to flare in Cosentyx versus placebo (p<.001) in pediatric ERA and JPsA patients.

Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation of psoriatic arthritis (PsA), moderate to severe plaque psoriasis, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)8.

Cosentyx received the EMA’s approval as a first-line systemic treatment for pediatric psoriasis in patients aged 6-18 years in July 2020. It recently received approval in the United States.

Shares of Novartis have gained 3.5% so far this year compared with the industry’s growth of 4.5%.

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Novartis’ performance in the first quarter was good as the lagging Sandoz business returned to growth and cardiovascular drug Entresto maintained its stellar performance.

However, Cosentyx sales came in at $1.1 billion and missed expectations by 2.44%.

Amgen’s AMGN Enbrel is approved for the treatment of moderately to severely active polyarticular JIA in children aged two years and older.

AMGN recorded $862 million of Enbrel sales in the first quarter. Sales decreased 7% year over year in the first quarter due to declines in net selling price and inventory levels.

Novartis currently carries a Zacks Rank #3 (Hold).

A couple of better-ranked stocks are Alkermes ALKS and Geron Corporation GERN. While Alkermes sports a Zacks Rank #1 (Strong Buy), Geron has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Loss estimates for ALKS for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed estimates in all of the trailing four quarters, the average surprise being 350.48%.

Loss estimates for GERN for 2022 have narrowed by 6 cents in the past 60 days. Geron surpassed estimates in three of the trailing four quarters, the average surprise being 1.07%.
 





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