What's Happening?
The European Commission has approved Otsuka's Dawnzera, a long-acting drug for hereditary angioedema (HAE), a rare disease characterized by recurrent attacks of swelling. Dawnzera, developed by Ionis, is an antisense oligonucleotide-based plasma prekallikrein
inhibitor. Clinical trials demonstrated that the drug significantly reduces the frequency of HAE attacks, with an 81% reduction in monthly attack rates when dosed every four weeks. Otsuka holds exclusive European rights to the drug, with plans to expand to Asia-Pacific markets. The approval triggers a $15 million milestone payment to Ionis.
Why It's Important?
Dawnzera's approval represents a significant advancement in the treatment of HAE, offering patients a less frequent dosing schedule compared to existing therapies. This could improve patient adherence and quality of life, as the drug can be self-administered with weeks between doses. The approval also highlights the potential of RNA-targeted therapies in managing rare diseases. With HAE affecting thousands in Europe and the US, Dawnzera could become a preferred prophylactic treatment, potentially capturing a significant market share and driving revenue for Otsuka and Ionis.
