Pakistan advances plan to bring Hepatitis Delta therapy under EUA route
ISLAMABAD: Pakistan has moved a step closer to improving access to treatment for Hepatitis Delta (HDV) after the Pakistan-China B2B Health Conference, where efforts led by Federal Minister for National Health Services, Regulations and Coordination Syed Mustafa Kamal pushed forward plans to introduce a breakthrough therapy for patients in the country through the Emergency Use Authorization (EUA) pathway.
The therapy has previously received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for the treatment of Hepatitis Delta, underlining its potential for a serious disease where major unmet medical needs remain.
For the last seven months, Minister Mustafa Kamal has been working closely with leading hepatologist Prof Dr Saeed Hamid and Pakistan’s clinical research expert Syed Munawar Ali to address the rising burden of Hepatitis Delta in Pakistan and speed up access to innovative treatment options.
Speaking on the significance of the initiative, the minister said Hepatitis Delta remains among the most serious forms of viral hepatitis. He cautioned that without timely intervention, the disease could continue to spread, putting people with weakened immune systems at particularly high risk of severe liver complications.
Following 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 moving ahead with the legal and scientific review required for EUA.
The process is being carried out in close collaboration with LCI Pharma, led by Chief Executive Officer Atif Siddiqui, to support the regulatory work 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 are still undiagnosed. The initiative is expected to strengthen the country’s response to the life-threatening disease by improving access to innovative therapies and expanding clinical research capacity.
The 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 also reflects the country’s growing role in international medical research and its commitment to bringing advanced treatments to patients.
The Ministry of National Health Services, DRAP, clinical researchers and industry partners have reaffirmed their joint 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.
