Jan 30 (Reuters) - Merck ( MRK ) plans to stop a
late-stage study testing its drug to treat pulmonary arterial
hypertension (PAH) ahead of time based on strong efficacy shown
in previous studies, the drugmaker said on Thursday.
The therapy, branded Winrevair, is already approved for
treating the rare condition which causes high blood pressure in
the lungs, leading to symptoms such as shortness of breath,
chest pain and dizziness.
Analysts expect Winrevair to become a multi-billion-dollar
product for Merck ( MRK ), which has been beefing up its portfolio of
cardiovascular drugs to counter a looming hit to sales of its
top-selling cancer treatment Keytruda from close copies.
Merck's ( MRK ) decision was partly based on interim data from
another late-stage study, named ZENITH, in which Winrevair
helped significantly reduce the risk of death in PAH patients.
"Based on the strong, positive interim efficacy data from
the ZENITH trial, as well as the totality of available Winrevair
data, we concluded that it would not be ethical to continue the
HYPERION study," said Eliav Barr, chief medical officer at
Merck ( MRK ).
The current study, named HYPERION, enrolled about 300 newly
diagnosed patients PAH patients who were randomly chosen to
receive Winrevair along with a background PAH therapy or placebo
and background PAH therapy.
The trial participants would be able to continue receiving
Winrevair through a separate open-label extension study, Merck ( MRK )
said, adding that it has discussed the decision with the U.S.
Food and Drug Administration.
Winrevair has brought in sales of $219 million since its
launch in March. Analysts expect the drug to bring in $1.5
billion in sales this year, according to LSEG data.
The therapy is also approved in the U.K., European Union and
30 other markets.