Pakistan moves closer to introducing breakthrough therapy for Hepatitis Delta

Islamabad: Pakistan has taken a major step toward improving access to treatment for Hepatitis Delta (HDV), following the Pakistan-China B2B Health Conference, where efforts led by Federal Minister for National Health Services, Regulations and Coordination, Syed Mustafa Kamal, advanced plans to introduce a breakthrough therapy for patients in Pakistan through the Emergency Use Authorization (EUA) pathway.

The therapy previously received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of Hepatitis Delta, reflecting its potential to address a serious disease with significant unmet medical need.

For the past seven months, Federal Minister Syed Mustafa Kamal has been closely working with leading hepatologist Prof. Dr. Saeed Hamid and Pakistan’s clinical research expert Syed Munawar Ali to address the growing burden of Hepatitis Delta in Pakistan and to accelerate access to innovative treatment options.

Speaking on the importance of the initiative, Minister Mustafa Kamal emphasized that Hepatitis Delta remains one of the most serious forms of viral hepatitis.

He warned that without timely intervention, the disease could continue to spread and place individuals with weakened immune systems at particularly high risk of severe liver complications.

As a result of the Minister’s continued engagement and follow-up, the Chief Executive Officer of the Chinese biotechnology company developing the therapy visited Pakistan during the B2B Health Conference.

Discussions with DRAP Chief Executive Officer Dr. Obaid Ullah Malik focused on facilitating the Phase III clinical development program in Pakistan through an accelerated regulatory pathway while simultaneously advancing the legal and scientific review required for Emergency Use Authorization.

These efforts are being undertaken in close collaboration with LCI Pharma, led by Chief Executive Officer Mr. Atif Siddiqui, to support the regulatory process and help make the treatment available to Pakistani patients at the earliest possible opportunity.

Health experts estimate that Pakistan may have more than one million suspected Hepatitis Delta patients, many of whom remain undiagnosed.

The initiative is expected to significantly strengthen Pakistan’s response to this life-threatening disease by improving access to innovative therapies and expanding clinical research capacity.

The breakthrough medicine has already undergone Phase II clinical evaluation in China, the United States, Mongolia, and Pakistan, where it demonstrated a favorable safety profile during clinical development.

Pakistan’s participation in the clinical program highlights the country’s growing contribution to international medical research and its commitment to bringing advanced treatments to patients.

The Ministry of National Health Services, DRAP, clinical researchers, and industry partners reaffirmed their shared commitment to completing the remaining regulatory requirements as quickly as possible while ensuring that all scientific, safety, and legal standards are fully met before the therapy becomes available to patients in Pakistan.