CSL celebrates dual FDA approvals

CSL (ASX:CSL) last week received US Food and Drug Administration (FDA) approval for two of the biotherapeutics company’s products.

On 24 May, the FDA approved FLUCELVAX QUADRIVALENT, a four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older. Developed by Seqirus (previously known as bioCSL), the vaccine is indicated for active immunisation for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

According to Seqirus President Gordon Naylor, FLUCELVAX QUADRIVALENT is “the first and only cell culture-derived seasonal influenza vaccine in the US to offer four-strain flu protection for people aged four years and older”. It is produced using full-scale cell culture manufacturing technology, which enables the potential for rapidly increased production of flu shots in response to outbreaks. Cell culture technology does not depend on eggs for manufacturing.

Two days later, the FDA approved AFSTYLA, CSL Behring’s long-lasting recombinant factor VIII single-chain therapy for adults and children with haemophilia A. AFSTYLA is indicated in adults and children with haemophilia A for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and the perioperative management of bleeding.

AFSTYLA is said to be the first and only single-chain product for haemophilia A that is specifically designed for long-lasting protection from bleeds, with twice-weekly dosing available. It uses a covalent bond that forms one structural entity, a single polypeptide-chain, to improve the stability of factor VIII and provide longer-lasting factor VIII activity.

The news follows the European Commission’s approval for IDELVION, the company’s treatment for haemophilia B (congenital factor IX deficiency), on 12 May. Suitable for all age groups, and recently approved in the US and Canada, the product delivers high-level protection maintaining factor IX activity levels above 5% in most patients over 14 days. As a result, appropriate patients can go up to 14 days between infusions and achieve excellent bleeding control. This also reduces the monthly number of units needed for prophylaxis therapy.

Regulatory agencies in Europe, Switzerland and Australia are currently reviewing CSL Behring’s licence applications for AFSTYLA. Agencies in Australia, Switzerland and Japan are currently reviewing CSL Behring’s licence applications for IDELVION.

CSL (ASX:CSL) shares were trading 0.48% lower at $11.585 as of around 11.30 am on Tuesday.