Idorsia has enlisted Antares Pharma, which makes an auto injector
for a generic version of Mylan's brand name EpiPen epinephrine
injector for severe allergic reactions, to make a device to deliver
selatogrel to patients who have already suffered a heart attack to
carry with them.
Idorsia's study will enrol some 14,000 patients at high risk of
recurrent AMI in about 30 countries and last several years.
Besides aspirin, there are no treatment options available for time
from onset of heart attack symptoms to first medical contact,
Idorsia said. Upon possible heart attack symptoms, patients would
self-inject selatogrel as early as possible, then seek medical help.
"From the moment that symptoms start, the clock is ticking," said
Martine Clozel, Idorsia's chief scientific officer and one half of
the married team behind the company spun off from Actelion following
its 2017 $30 billion sale to Johnson & Johnson.
She said experimental selatogrel was designed to halt clot formation
after a heart attack, buying time for people to get proper medical
help while limiting damage.
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A spokesperson said Idorsia
worked with Antares to develop an injector
tailored to the needs of those at risk of
another heart attack. About 200,000 people
annually who have had a heart attack suffer from
another one in the United States, according to
the U.S. Centers for Disease Control and
Prevention.
In December, the U.S. Food and Drug
Administration (FDA) designated investigation of
selatogrel as a "fast-track" development
programme, Idorsia noted.
Idorsia this year filed for approval of its
insomnia drug daridorexant, with the FDA due to
make a decision in coming months.
(Reporting by Paul Arnold and John Miller in
Zurich; Editing by Michael Shields and David
Evans)
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