CSL shares jumped more than 1.6%, or close to $1.58 yesterday after the company revealed that US drug regulators will review the company’s latest treatment for the blood disease haemophilia after a clinical trial showed promising results.
CSL told the ASX that the US Food and Drug Administration has accepted for review CSL’s licence application for its recombinant single-chain factor VIII treatment for haemophilia A.
CSL shares closed at $96.23 yesterday, a nice rise in a mixed day’s trading on news from the US about the new treatment.
CSL 1Y – CSL haemophilia therapy passes to US review stage
It’s said to be a promising treatment for a niche part of the haemophilia cluster of blood disorders.
Haemophilia is a potentially life-threatening blood clotting disorder because there is insufficient clotting factor VIII or IX in the blood to help control bleeding.
Those affected by haemophilia can experience prolonged or spontaneous bleeding in the muscles, joints or internal organs.
The condition affects more than 175,000 people worldwide, most of whom have haemophilia A.
CSL chief scientific officer Dr Andrew Cuthbertson said CSL has the only recombinant single-chain factor VIII product in late-stage development for the management of haemophilia A.
"CSL Behring has one of the industry’s largest portfolios of biotherapies that improve the care and well-being of patients with a bleeding disorder,” Dr Cuthbertson said yesterday.
“Our scientific expertise and relationship with the bleeding disorders community led us to seek further advancements in the care and treatment of haemophilia.
“We are excited to be one step closer to providing this innovative treatment to patients in the US,” Dr Cuthbertson said yesterday’s statement.
Patients may also require fewer doses of the treatment which CSL says is designed to last longer.
It’s big business for CSL – in the first half of the June 30 financial year, haemophilia product sales for CSL totalled $US558 million ($A768 million).
