ZURICH (Reuters) – Swiss drugmaker Novartis grabbed a key European panel’s recommendation for its prospective cholesterol drug Leqvio on Friday, clearing the way for its approval in the next couple of months.
Novartis is also counting on approval from U.S. regulators before the end of the year for the drug, also known as inclisiran, which the Basel-based drugmaker bought in a deal last year for nearly $10 billion and predicts will be a top seller.
Novartis got the nod from European Medicines Agency’s Committee for Medicinal Products, which the European Commission nearly always follows. Heart disease is a top killer worldwide, and Novartis with its so-called small-interfering RNA drug is targeting patients whose low-density lipoprotein, or LDL cholesterol, levels have not sufficiently been brought down by existing medications like statins.
“Despite all the therapies we have available for these patients, about 80% of patients don’t achieve the LDL targets they need to in order to protect themselves from cardiovascular events,” Novartis cardiovascular and metabolic drug development chief David Soergel said in an interview on Friday. “We see inclisiran as a great option for them.”
(Reporting by John Miller; Editing by Michael Shields)