Amidst Strong Quarterly Growth, Novartis Receives FDA Complete Response Letter for Canakinumab

Novartis logo on side of building

Denis Linine /

Buried deep in an announcement touting a 6 percent growth in net sales driven by strong revenue gains of Cosentyx, Swiss pharma giant Novartis reported it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for canakinumab as a potential treatment for cardiovascular risk reduction.

In a brief note in its announcement, Novartis said it received the CRL earlier this month regarding its supplemental Biologics License Application for canakinumab. Novartis said it is evaluating the FDA’s feedback. Canakinumab is marketed as Ilaris for a number of indications, including periodic fever syndromes. Earlier this year, Novartis released data that showed canakinumab, an IL-1B inhibitor, has demonstrated clinical success in the treatment of gout, a form of arthritis that occurs due to the accumulation of urate crystals in the joints. That information about gout was secondary information from the company’s CANTOS trial, which is examining the effect of canakinumab as a secondary prevention of cardiovascular events.

While the CRL is certainly a setback for the company, Novartis had plenty of positive news to share in its quarterly financial report. Sales of Cosentyx grew to $750 million, a 37 percent increased, the company said. Additionally, sales of heart failure drug Entresto jumped 113 percent to $271 million. Novartis said the sales spike was driven by “continued uptake worldwide.” Novartis also noted that Revolade drew #295 million, a 32 percent increase, and Jakavi earned $248 million, a 27 percent increase. Orphan drug Lutathera, which was approved in January for the treatment of somatostatin-receptor positive gastroenteropancreatic neuroendocrine tumors, snagged $56 million, the company added.

In total, Novartis said net sales for the quarter were $12.8 billion, with the aforementioned drugs being the primary drivers.

Novartis Chief Executive Officer Vas Narasimhan also pointed to some of the clinical successes the company experienced over the quarter. In particular, he pointed to gene-therapy treatment AVXs-101, which it acquired earlier this year in the $8.7 billion acquisition of Illinois-based AveXis. During the quarter the company filed regulatory submissions in the United States, Europe and Japan for approval of AVXS-101 as a treatment for spinal muscular atrophy. If approved, the company said it will look to launch the drug in the middle of 2019. Also in the quarter, Novartis filed for approval of siponimod for secondary progressive multiple sclerosis. In the United States, the company filed for approval with the use of a priority review voucher. Late-stage data showed siponimod-dosed patients gained a significant benefit in cognitive processing speed. If approved, Novartis said it will also look to launch the medication in early 2019.

In its announcement this morning, Novartis also took the opportunity to announce another acquisition, Indiana-based Endocyte for $2.1 billion. The deal will allow the company to expand its radiopharmaceuticals business with the late-stage therapy, Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer.

Other quarterly highlights included a 5 percent growth in sales of Alcon and the hiring of Klaus Moosmayer as the company’s new chief ethics officer. It wasn’t all rosy though. Novartis noted that its subsidiary Sandoz saw a 6 percent decline in sales to $2.4 billion. Last month Novartis agreed to sell 300 Sandoz assets, including the Sandoz U.S. dermatology business and U.S. oral solids portfolio, to Aurobindo Pharma for about $1 billion.

Barring unforeseen events, Novartis said it has revised its 2018 guidance for group net sales. The company said it now expects to see mid-single digit growth. The company also expects mid to high-single-digit growth for its operating income guidance.

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