- Counterbalancing Novartis' otherwise positive third quarter earnings, the Swiss pharma giant disclosed Thursday that regulators rejected an application aimed at getting its drug canakinumab approved for cardiovascular risk reduction.
- The rejection is noteworthy, given positive data from the Phase 3 CANTOS study that Novartis unveiled last year. Those results showed canakinumab not only outperformed placebo in lowering the risk of major adverse cardiovascular events (MACE), but also improved heart health by curbing inflammation. The company said it's evaluating the feedback provided by the Food and Drug Administration in a Complete Response Letter.
- Canakinumab has been on the U.S. market for nearly a decade under the brand name Ilaris. After getting an initial nod from the FDA in 2009 for a group of rare auto-inflammatory disorders, Ilaris has secured multiple other indications, including systemic juvenile idiopathic arthritis and several uncommon diseases that cause periodic fever and inflammation.
Novartis executives haven't had much time to pour over the FDA's rejection, noting on the company's Oct. 18 earnings call they just received the canakinumab CRL the day prior.
"We're continuing to explore additional information based on the information that we received from the FDA, and we'll have further understanding as we move forward," John Tsai, Novartis' head of global drug development and chief medical officer, said on the call.
Whatever the agency's issues are with canakinumab, Novartis has shown it's willing to put significant resources behind the drug. The CANTOS study alone enrolled more than 10,000 patients and took six years to complete.
In that study, patients on a 150 mg dose regimen of canakinumab experienced a 15% relative risk reduction of a composite of MACE, as measured by a composite of nonfatal heart attacks, nonfatal strokes and cardiovascular death. Responses were particularly beneficial for patients whose levels of high sensitivity C-reactive protein (hsCRP), viewed as a risk factor for heart disease, fell below 2 mg/L during the trial.
"Regarding the canakinumab CRL, as we saw from the CANTOS trial, we knew that the patients who achieved hsCRP less than 2 received the most benefit," Tsai said in discussing the CRL.
If Novartis can remedy the canakinumab concerns and get an approval for cardiovascular risk reduction, it would likely give the pharma's cardio-metabolic business a boost.
Currently, Entresto (sacubitril and valsartan) is responsible for almost all the revenue coming from that business. And while the heart medication is experiencing strengthening growth, another new product wouldn't hurt, given that Novartis is facing headwinds in other units like ophthalmology and established medicines.