Canadians Living with Primary Biliary Cholangitis (PBC) One Step Closer to New Treatment Option as Gilead Reaches Milestone National Agreement for LYVDELZI® (seladelpar)

Successful completion of pan-Canadian negotiations paves the way for provinces and territories to publicly fund an innovative therapy for primary biliary cholangitis (PBC)

MISSISSAUGA, ON, Oct. 27, 2026 /CNW/ -- Canadians living with primary biliary cholangitis (PBC), a rare and chronic liver disease, are one step closer to accessing a new publicly funded treatment option. Gilead Sciences, Inc. (NASDAQ: GILD) announced today that it has successfully concluded negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for LYVDELZI (seladelpar), reaching an agreement on the terms for public reimbursement.

This agreement marks a critical step towards treatment of PBC: it clears the national pricing hurdle and opens the door for participating provincial, territorial, and federal public drug plans to add LYVDELZI to their public formularies.

A Milestone for an Underserved Patient Community

Primary biliary cholangitis (PBC) is a progressive autoimmune condition that damages the bile ducts in the liver. Over time, it can cause severe liver damage and significantly impact a person's quality of life. Because treatment options have historically been limited, expanding access to innovative medicines addresses a critical unmet need for Canadian patients and their families.

"Every step forward in liver health is a victory for patients who are navigating a lifelong, unpredictable disease like PBC," said Paul Petrelli, General Manager, Gilead Sciences Canada. "Reaching an agreement with the pCPA is a pivotal moment. Our focus now turns to collaborating with provincial and territorial governments to help make this medicine publicly accessible to the Canadians who need it as swiftly as possible."

"This is an important milestone for the PBC community that brings us hope," said Gail Wright, President of the Canadian PBC Society. "PBC patients often suffer from debilitating symptoms, along with the constant worry of irreversible liver damage. Access to new treatments through public drug plans is an important step forward that will make a real difference in the lives of people living with PBC."

What This Means for Canadians: The Path Ahead

With national negotiations successfully finalized, individual provincial, territorial, and federal drug plans will now review LYVDELZI to determine formulary listings and confirm reimbursement criteria. While rollout timing varies across jurisdictions, some public drug plans could begin reimbursing eligible patients as early as 2027.

As reimbursement agreements are reached with participating jurisdictions, currently enrolled patients in the Momentum Support Program will be transitioned to public plans.

About PBC 

PBC is a chronic, autoimmune disease of the bile ducts that affects approximately 143,000 people in North America. PBC is more common in women and causes liver damage that can progress to liver failure and result in the need for liver transplant, if left untreated. The most common symptoms of PBC are pruritus (chronic itch) and fatigue, which up to 80% of people living with PBC can experience and can profoundly compromise quality of life. Symptoms of PBC are often invisible to others and the journey to a PBC diagnosis can be long and challenging.

There is currently no cure for PBC, and treatment goals include reducing the risk of disease progression and reducing the symptoms related to cholestasis (impaired bile flow), such as cholestatic itch. The effect is primarily measured by an improvement in liver biochemical tests, including the improvement and normalization of alkaline phosphatase (ALP) levels, an important marker associated with long‑term outcomes in PBC.

About Gilead Sciences 

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. 

In 2025, Gilead announced a $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.

Indications and Clinical Use:

LYVDELZI (seladelpar) is indicated for the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in adults unable to tolerate UDCA.

LYVDELZI has been granted a Notice of Compliance with conditions (NOC/c), pending the results of trials to verify its clinical benefit.

For prescribing and safety information, please consult the LYVDELZI Product Monograph here for important information relating to clinical use, contraindications, warnings and precautions, adverse reactions, drug interactions, and dosing information. The product monograph is also available by calling 1-866-207-4267.

LYVDELZI, Momentum, Gilead, their respective logos, and GSI are trademarks of Gilead Sciences, Inc. or its related companies.

For more information about Gilead Sciences Canada, please visit the company's website at https://www.gilead.ca, follow Gilead on LinkedIn (@GileadSciencesCanada), or email Gilead Public Affairs at [email protected].

SOURCE Gilead Sciences, Inc.