Novartis withdraws all statin agents from the Korean mkt

Novartis reported the discontinuation of supply of its Lescol XL Tab to the Ministry of Food and Drug Safety (MFDS)

Falling behind the competition among other statin agents…2024 performance amounted to merely KRW 2.8 billion

Product photo of Lescol

Novartis is withdrawing all its statin agents used to treat hyperlipidemia from the Korean pharmaceutical market.

Analysis suggests that the product's competitiveness has weakened due to other statin agents.

According to the Ministry of Food and Drug Safety (MFDS) on the 2nd, Novartis Korea reported discontinuing supply of 'Lescol XL Tab (fluvastatin sodium),' the company's only statin-containing drug.

Novartis stated, "In accordance with our global strategy and supply planning, we are discontinuing the supply of Lescol XL extended-release Tablet."

The supply discontinuation date is set for July 31. Novartis noted, "Following the discontinuation of supply, please consider substituting with other statin-based products of the same mechanism of action (e.g., rosuvastatin, atorvastatin, simvastatin, pravastatin, etc.)."

Lescol XL Extended-Release Tablet is currently the only statin product from Novartis that remains approved.

Novartis entered the statin market in Korea in 1994, after obtaining MFDS approval for Lescol capsule. However, the product failed to achieve high performance as it lost out in competition with other statin products.

Consequently, five of the six approved fluvastatin items were removed from the approval list in 2022 and 2023 due to withdrawals.

Lescol XL was the only remaining product. However, following the latest report of supply discontinuation, fluvastatin will be completely withdrawn from the Korean market. There are currently no separate generic items available.

Lescol XL Tab is indicated for ▲reduction of risk for cardiovascular disease, ▲hyperlipidemia ▲an adjunct to diet to reduce elevated total cholesterol, LDL-cholesterol, apo-B protein, and triglyceride levels and to increase HDL-cholesterol in pediatric and adolescent patients (boys: aged 9 to 16; girls: aged 10 to 16 and post-menarche) with heterozygous familial hypercholesterolemia who do not respond adequately to dietary therapy.

Based on 2024 UBIST data, outpatient prescription amount totaled KRW 2.8 billion, a 23.7% decrease from the previous year. The sales volume is considered small when compared to Viatris' Lipitor (atorvastatin calcium trihydrate), a statin agent, which recorded KRW 188.6 billion in prescription sales during the same period.

The underperformance is considered the most significant factor in this withdrawal from the Korean market.