ISLAMABAD: Pakistan has taken a major step towards improving access to treatment for Hepatitis Delta (HDV) after the Pakistan-China B2B Health Conference advanced plans to introduce a breakthrough therapy for patients through the Emergency Use Authorization (EUA) pathway.
The initiative has been led by Federal Minister for National Health Services, Regulations and Coordination Syed Mustafa Kamal, who has been working for the past seven months with leading hepatologist Prof Dr Saeed Hamid and clinical research expert Syed Munawar Ali to address the growing burden of Hepatitis Delta in the country and accelerate access to innovative treatment options.
The therapy has previously received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for the treatment of Hepatitis Delta, reflecting its potential to address a serious disease with significant unmet medical need.
Speaking on the initiative, Minister Mustafa Kamal said Hepatitis Delta remained one of the most serious forms of viral hepatitis. He warned that without timely intervention, the disease could continue to spread and pose a particularly high risk of severe liver complications for individuals with weakened immune systems.
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 Drug Regulatory Authority of Pakistan (DRAP) Chief Executive Officer Dr Obaid Ullah Malik focused on facilitating the Phase III clinical development programme in Pakistan through an accelerated regulatory pathway, while also advancing the legal and scientific review required for Emergency Use Authorization.
The efforts are being undertaken in close collaboration with LCI Pharma, led by Chief Executive Officer 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 strengthen Pakistan’s response to the 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 favourable safety profile during clinical development. Pakistan’s participation in the clinical programme 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.
