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Vertex (VRTX) Kaftrio Gets Europe Nod for CF in Children

The European Commission approves Vertex's (VRTX) triple combination therapy, Kaftrio, in combination with Kalydeco for treating cystic fibrosis in children aged between six and 11 years.

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This story originally appeared on Zacks

Vertex Pharmaceuticals VRTX announced that the European Commission (“EC”) approved a label expansion of its triple combination cystic fibrosis regimen, Kaftrio. Following the approval, Kaftrio (ivacaftor/tezacaftor/elexacaftor) will be available in Europe to treat cystic fibrosis (“CF”) in patients aged 6 through 11 years who have at least one F508del mutation in the CF transmembrane conductance regulator (CFTR) gene in combination with Kalydeco (ivacaftor).

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The approval was based on clinical data, which demonstrated that treatment with the combination of Kaftrio and Kalydeco achieved improvements in lung function, sweat chloride and respiratory symptoms that were consistent with improvements achieved in the approved CF patient population aged 12 years or older. The safety and tolerability profile of the combination regimen in children aged 6 through 11 years was also consistent with the approved patient population.

Please note that the Kaftrio and Kalydeco combo is available for CF patients aged 12 years or older since last year and continues to demonstrate clinical benefit in this patient population.

With this approval, approximately 1,500 new patients will be eligible to receive treatment with this combination regimen.

Please note that in the United States, Trikafta (Kaftrio’s name in the United States) was approved by the FDA in combination Kalydeco to treat CF in children aged six to 11 years in June last year.

Shares of Vertex have declined 1.4% in the past year compared with the industry’s decrease of 31.3%.

Zacks Investment ResearchImage Source: Zacks Investment Research

We note that CF is a rare life-shortening genetic disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract.

In the first nine months of 2021, Trikafta generated sales worth $4 billion, up 44% year over year, driven by the high level of treatment penetration in the United States and strong launch in international markets. Trikafta/Kaftrio is crucial for Vertex’s long-term growth as it has the potential to treat up to 90% of CF patients.

It has seen substantial uptake across all European countries where the company secured reimbursement agreements, most importantly in the large markets of Germany and the United Kingdom.

Zacks Rank and Stocks to Consider

Vertex currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Regeneron Pharmaceuticals REGN, Repligen Corporation RGEN and Adaptive Biotechnologies ADPT, all carrying a Zacks Rank #2 (Buy) at present. You can see  the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Estimates for Regeneron have improved from earnings per share of $67.33 to $70.62 for 2021 and from $46.98 to $48.06 for 2022 over the past 60 days.

Regeneron delivered an earnings surprise of 28.93%, on average, in the last four quarters. Shares of REGN have gained 23.8% in the past year.

Repligen’s earnings estimates have been revised upward from $2.88 to $2.90 for 2021 and from $3.20 to $3.22 for 2022 over the past 60 days.

Repligen delivered an earnings surprise of 49.21%, on average, in the last four quarters. Shares of RGEN have gained 2.1% in the past year.

Adaptive Biotechnologies’ loss estimates have narrowed from $1.48 to $1.47 for 2021 and $1.56 to $1.51 for 2022 over the past 60 days.

Adaptive Biotechnologies delivered an earnings surprise of 11.21%, on average, in the last four quarters.



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