CSL (ASX:CSL) said it is experiencing a temporary global shortage of its one-time gene therapy infusion, Hemgenix, also known as etranacogene dezaparvovec-drlb, which may delay treatment for some patients in countries with commercial access, the biotechnology company said in a statement on Wednesday.
The company emphasizes that this issue is not related to safety or effectiveness but rather highlights the complexity of manufacturing gene therapies while upholding the highest regulatory and quality standards.
The company said it is working with authorities to stabilize supply and ensure eligible individuals have timely access and information.
The company's shares fell around 1% in recent Wednesday trade.