HLS gets approval for Nilemdo; Nezlizet needs more data

Executive Summary

• Health Canada approved HLS Therapeutics’ oral LDL‑cholesterol lowering therapy Nilemdo (bempedoic acid) for Canadian patients at risk of cardiovascular disease.
• The approval grants eight years of data protection from 17 Nov 2025 and, together with existing patents, extends market exclusivity to 2040.
• HLS plans to launch Nilemdo in Canada in Q2 2026; a notice of non‑compliance (NON) was issued for Nexlizet, which will be addressed separately.

Key Details

• Approval Scope: Nilemdo approved for reduction of LDL‑C and risk of major cardiovascular events in adults who cannot achieve target LDL‑C levels with existing therapies or are statin‑intolerant.
• Regulatory Timeline: Approval issued 17 Nov 2025; data protection runs for eight years, extending market exclusivity to 2040 pending patent registrations.
• Launch Plan: Commercial launch in Canada targeted for Q2 2026.
• Clinical Support: Approval based on the CLEAR Outcomes trial (≈14,000 patients) showing a statistically significant reduction in major adverse cardiovascular events (MACE).
• Market Opportunity: Over 500,000 Canadians potentially eligible for bempedoic‑acid therapy.
• Nexlizet Status: Health Canada issued a NON citing CMC and biopharmaceutics deficiencies; no clinical safety/efficacy concerns were raised. HLS will submit additional data to resolve the issues.
• Strategic Impact: Adds Nilemdo to HLS’s cardiovascular portfolio alongside Vascepa, positioning the company as a leader in oral CV medicines in Canada.

Notable Quotes

“This approval represents a major milestone for HLS and for the many Canadians striving to better manage their cardiovascular health,” – Craig Millian, CEO, HLS Therapeutics.

“Nilemdo strengthens our cardiovascular portfolio and, along with Vascepa, positions HLS as a leader in bringing novel oral CV medicines to the Canadian market.” – Craig Millian, CEO, HLS Therapeutics.