Approval

Novartis To Test Novel Launch Strategy For Cholesterol Drug Leqvio

December 27,2021 10:35 AM
- By Admin

To avoid the fate of PCSK9 inhibitors Repatha (evocolumab) and Praluent (alirocumab), which have muddled through underwhelming launches in recent years, Novartis Pharmaceuticals President Marie-France Tschudin said the company plans to work directly with the top 200 hospital systems in the US to identify patients who would be most likely to benefit from Leqvio (inclisiran). 

Time will tell whether its launch strategy will translate into improved uptake versus the PCSK9 drugs that came before it. 

What happened

The FDA approved Leqvio, a PCSK9-targeting siRNA therapy, to lower LDL cholesterol. 

Leqvio is administered twice per year after two initial doses within the first three months of treatment. Novartis plans to launch the drug in early January 2022 at $3,250 per dose, which would be $9,750 the first year and $6,500 in subsequent years.  

The backstory

While the FDA issued a complete response letter for Leqvio in December 2020, citing an inspection issue at a third-party manufacturing facility, analysts and physicians largely believe the molecule could change the way high cholesterol is treated given the convenience of its twice-yearly dosing profile. 

Many analysts think Novartis overpaid to acquire Leqvio’s originator The Medicines Company for $9.7 billion in late 2019. But the pharma has suggested that the regulatory delay may have been a blessing in disguise, allowing it more time to prepare for a launch with fewer COVID-related headwinds. 

What matters most

Novartis’ hope is that it will be able to reach a broad swath of patients with Leqvio by working directly with hospital systems using what Tschudin calls a “population health-like approach.” 

"Cardiologists aren’t used to "buy and bill", they’re not really sure what sort of burden that will be on their own practice," Tschudin told FirstWord. "In order to make that easier for them, we’ve also partnered with about 1,100 alternative injection centers or sites so that those practices don’t need to buy and bill. The alternative injection centers will be the ones doing it and they are used to that."

She added that if successful, launch strategy could be applied to other disease areas. “The NHS is already looking at this for diabetes and for respiratory disease