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Novartis said Friday that last year was one of its “strongest” financial performances in its history following a multiyear reorg as a pure-play pharma company, bolstered by steady growth of its top three medicines and a skyrocketing cholesterol franchise. CEO Vas Narasimhan said on a media call that the company exceeded its full-year guidance for both sales and operating income. The Swiss drugmaker’s 2024 sales grew 12% to $45.4 billion, according to an earnings release . The update was not a complete surprise, because the company upped its sales guidance through 2028 in November. Novartis’ cholesterol drug Leqvio saw the most growth in 2024, with sales soaring 112% to $754 million. But its top three best sellers were heart failure medicine Entresto ($7.8 billion), psoriasis treatment Cosentyx ($6.1 billion) and multiple sclerosis drug Kesimpta ($3.2 billion). In 2023, the company completed a long-term restructuring process that saw it integrate its pharmaceuticals and oncology business units into a so-called innovative medicines unit, and zero in on four core therapeutic areas: cardiovascular, renal and metabolic (CRM), as well as oncology, immunology and neuroscience. “When you look at [this change] from a value creation standpoint, in January 2018 the market capitalization of Novartis was $196 billion, and you can see today that [it] stands at over $200 billion,” Narasimhan said on the second media call. “The strategy of focusing the company has unlocked value and actually enabled Novartis to be much stronger for the long run.” Last year, the drugmaker slashed the size of its development and commercial functions with an eye to a leaner structure that would allow it to focus on “the biggest opportunities” in its pipeline. It’s targeting 15 new launches or label expansions over the next few years, starting with a potential indication for its immunoglobulin A nephropathy drug Fabhalta. The factor B inhibitor was due for an FDA adcomm meeting next month to discuss its risk-benefit profile in C3 glomerulopathy, but the agency called the meeting off earlier this week. “Our understanding is that the FDA no longer deemed it necessary to hold an advisory committee meeting,” Narasimhan told reporters. “We think it’s based on the overall data package we’ve been able to generate and the additional follow-on data that we’ve provided.” Narasimhan also stressed that Novartis remains a leader in the radiopharmaceutical space, with close to $2 billion in yearly sales from radioligand products, a global manufacturing footprint and more than 15 assets in the clinic using lutetium or actinium isotopes. The company made several investments in the approach last year, including a $1 billion bet on Mariana Oncology. Novartis plans to carry on with this kind of dealmaking , Narasimhan said. “But I think it’s really important to note that right now, lutetium is the isotope that has the most data and is the only approved isotope,” he continued, adding that newer isotopes such as actinium and lead have yet to demonstrate the necessary risk-benefit profile for approval and broad use. Also on the call, the company’s chief medical officer Shreeram Aradhye said it had discontinued development of a Phase 2 candidate for Sjögren’s syndrome. Novartis dropped work on anti-CD40 antibody iscalimab because its risk-benefit profile to date was not competitive, Aradhye said. But the company is still advancing another antibody program for Sjögren’s called ianalumab. In 2022, the drugmaker gave up on advancing iscalimab for liver transplant patients for similar reasons. Editor’s note: This story has been updated to add more comments from the company’s calls.

An FDA advisory committee meeting for a kidney drug has been canceled, and another meeting to discuss opioids has been delayed, amid ongoing confusion and disruption in several US government health care programs as the Trump administration takes over. The cause of the adcomm meeting changes wasn’t immediately clear, and the FDA didn’t respond to questions about whether they were part of other operational and funding pauses ordered by the new administration. A Feb. 24 meeting, now canceled, had been scheduled to consider a label expansion of Novartis’ hematology and nephrology drug Fabhalta. The company has an application with the FDA to use the drug as a treatment for the ultra rare kidney disease known as complement 3 glomerulopathy (C3G), which has no approved treatments. The company said by email Tuesday that “the FDA has informed us it will no longer convene the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) to discuss the supplemental New Drug Application.” Novartis didn’t say why the meeting was canceled, or whether it was related to the new administration, the resolution of other safety and efficacy questions, or for another reason. An FDA decision on the application is expected in the first half of 2025. In addition, a Feb. 5 meeting on opioids before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products advisory committees has been postponed. Stanford’s Brian Bateman, chair of the Anesthetic and Analgesic Drug Products committee, told Endpoints News on Tuesday that he received an email indicating that the meeting was postponed, but there has been “no other communication at this point.” The meeting — which was removed from the FDA’s advisory committee calendar — was to discuss two postmarket requirements, including prospective and retrospective epidemiologic studies that examined “the serious risks and predictors of misuse, abuse, addiction, and fatal and non-fatal opioid overdose in patients with long-term use of opioid analgesics for management of chronic pain,” the FDA said in December. The FDA and other members of the AADPAC didn’t respond to requests for comment.