By Sahil Pandey
March 17 (Reuters) - Australia's CSL CSL.AX said it is facing a temporary global stockout of its bleeding disorder gene therapy Hemgenix, which will delay treatment for some patients in countries where the drug is already commercially available.
Here are some details:
CSL said the supply issue is not linked to the safety or effectiveness of Hemgenix, but to the complexity of making gene therapies and the company's quality standards.
Hemgenix is a one-time intravenous gene therapy for adults with hemophilia B, a rare inherited condition that makes it hard for blood to clot.
The company said it is working with regulators on steps to secure a stable supply of Hemgenix while maintaining high manufacturing and quality requirements.
U.S. drugmaker Pfizer PFE.N had stopped global development and commercialization of its hemophilia gene therapy, Beqvez, last year citing soft demand from patients and their doctors.
Hefty price tags, logistical issues and the prospect of potential treatment advances were holding back the adoption of gene therapies for hemophilia, according to doctors.
CSL said the delay could affect some eligible patients who were planning to receive the one-time treatment in countries with existing access.
The company said it remains confident in Hemgenix and is committed to making the treatment available to adults with hemophilia B when supply allows.
(Reporting by Sahil Pandey in Bengaluru)
((Sahil.Pandey@thomsonreuters.com;))