beeldscherm schreef op 16 augustus 2018 14:14:
Lanadelumab and the market
for hereditary angioedema treatments
Shire’s novel drug that prevents angioedema, lanadelumab (a fully human
monoclonal antibody which inhibits plasma kallikrein), could enter the market in
late 2018. Regulatory filings were submitted in the U.S. and EU in February 2018 with
Priority Review and accelerated assessment granted in the U.S. and EU, respectively.66,67
Shire’s Cinryze (C1 esterase inhibitor [human]) is the dominant brand for
prevention of angioedema attacks, but one of its main drawbacks is its
intravenous administration. The first subcutaneous product to prevent
attacks of angioedema was CSL Behring’s Haegarda, launched in mid2017
and also a C1 esterase inhibitor. However, despite Haegarda’s
first-mover advantage, lanadelumab is set to dominate the market for
first-line prevention of angioedema attacks in patients with hereditary
angioedema and significantly increase the use of such prophylactic
medications due to its superior efficacy and more convenient dosing.
In the phase 3 HELP study, lanadelumab significantly reduced the mean
frequency of angiodema attacks in patients with hereditary angiodema by
87% versus placebo.68 These findings compare favorably to the 84% and 54%
reductions in attacks reported for Haegarda69 and Cinryze70, respectively.
While both Haegarda and Cinryze require twice-weekly dosing, lanadelumab is
dosed once every two weeks with potential for once-monthly dosing. Lanadelumab
also has a smaller injection volume than Haegarda, allowing for more rapid
injection, thereby giving it a competitive edge that will see blockbuster revenue
Sales of Cinryze are expected to decline from $665 million in 2018 to $283
million in 2022. Meanwhile lanadelumab is forecast to start out with modest
sales of just $74 million in 2018, increasing to $1.153 billion in 2022.
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