CSL is now such a dominant player in the global blood products markets (and a major presence on the ASX) that news of approval of a new potentially important product is big news indeed – more so than for many smaller companies.
CSL is the second biggest blood products company globally and for years it has been talking about a new haemophilia B drug, called Idelvion, and how it was wending its way through the approval processes of regulators in major global markets. Lately the company has become more confident that the new drug would soon win approvals.
Yesterday CSL told the ASX that the new product has been approved for use in the US by the country’s powerful Food & Drug Administration.
CSL expects Idelvion will be available in the US in the next month.
The key European regulator, the European Medicines Agency’s Committee for Medicinal Products for Human Use, last month recommended granting marketing authorisation for Idelvion in the European Union. Canadian regulators have also approved the drug’s use.
And regulators in Australia, Switzerland and Japan are also currently reviewing CSL’s license applications for the drug.
"Idelvion has the potential to significantly impact the treatment of haemophilia B as it maintains factor nine activity levels above 5 per cent over a prolonged of time. This provides excellent bleeding control,” CSL chief scientific officer Andrew Cuthbertson said in a statement to the ASX.
“Idelvion is the first product from our innovative recombinant factor development program to receive FDA approval.
"We are proud to add this therapy to our growing portfolio of bleeding disorder products, and are particularly excited abut the positive impact treatment with Idelvion can have on the well-being with patients with haemophilia B."
The global haemophilia market is worth about $US10.5 billion ($A14 billion) and the market has been shifting towards recombinant treatments and away from plasma-derived therapies.
Of this $US10.5 billion, the haemophilia B market is worth about $US1.3 billion, the majority of which comes from the US and European markets.
Haemophilia B almost exclusively affects males with about one in 25,000 suffering from the disorder.
The new treatment protects patients from bleeding episodes for up to 14-days, which means people living with haemophilia B can inject themselves with the therapy weekly or fortnightly rather than two to three times a week.
CSL shares rose 0.6% to $103.24.
